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Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01901653
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : July 11, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Stemcentrx

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Small Cell Lung Cancer
Intervention Drug: Rovalpituzumab tesirine (SC16LD6.5)
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC) Phase 1a: Cohort 2 (SCLC) Phase 1a: Cohort 3 (SCLC) Phase 1a: Cohort 4 (SCLC) Phase 1a: Cohort 5 (SCLC) Phase 1a: Cohort 6 (SCLC) Phase 1a: Cohort 7 (SCLC) Phase 1a: Cohort 8 (SCLC) Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC) Phase 1b: Retreatment (SCLC) Phase 1b: Retreatment (LCNEC) Phase 1b: Maintenance (SCLC) Phase 1b: Maintenance (LCNEC)
Hide Arm/Group Description SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
Period Title: Overall Study
Started 3 1 11 3 2 3 7 10 1 18 2 16 5
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 3 1 11 3 2 3 7 10 1 18 2 16 5
Reason Not Completed
Death             2             1             8             3             2             2             6             9             1             16             2             15             4
Lost to Follow-up             1             0             2             0             0             1             0             1             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             1             0             0             0             0             0             0
Alive at Study Termination by Sponsor             0             0             1             0             0             0             0             0             0             2             0             1             1
Arm/Group Title Phase 1a: Cohort 1 (SCLC) Phase 1a: Cohort 2 (SCLC) Phase 1a: Cohort 3 (SCLC) Phase 1a: Cohort 4 (SCLC) Phase 1a: Cohort 5 (SCLC) Phase 1a: Cohort 6 (SCLC) Phase 1a: Cohort 7 (SCLC) Phase 1a: Cohort 8 (SCLC) Phase 1a: Cohort 8 (LCNEC) Phase 1b: Retreatment (SCLC) Phase 1b: Retreatment (LCNEC) Phase 1b: Maintenance (SCLC) Phase 1b: Maintenance (LCNEC) Total
Hide Arm/Group Description SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle Total of all reporting groups
Overall Number of Baseline Participants 3 1 11 3 2 3 7 10 1 18 2 16 5 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 11 participants 3 participants 2 participants 3 participants 7 participants 10 participants 1 participants 18 participants 2 participants 16 participants 5 participants 82 participants
<=18 years 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Between 18 and 65 years 3 1 6 2 2 1 5 7 1 11 1 9 2 51
>=65 years 0 0 5 1 0 2 2 3 0 7 1 7 3 31
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 11 participants 3 participants 2 participants 3 participants 7 participants 10 participants 1 participants 18 participants 2 participants 16 participants 5 participants 82 participants
Female 2 1 4 2 1 1 2 4 0 11 0 4 2 34
Male 1 0 7 1 1 2 5 6 1 7 2 12 3 48
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 11 participants 3 participants 2 participants 3 participants 7 participants 10 participants 1 participants 18 participants 2 participants 16 participants 5 participants 82 participants
Hispanic or Latino 0 0 0 0 0 0 0 0 0 1 0 0 0 1
Not Hispanic or Latino 3 1 10 3 2 3 7 10 1 14 2 15 4 75
Unknown or Not Reported 0 0 1 0 0 0 0 0 0 3 0 1 1 6
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 11 participants 3 participants 2 participants 3 participants 7 participants 10 participants 1 participants 18 participants 2 participants 16 participants 5 participants 82 participants
American Indian or Alaska Native 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Asian 0 0 0 0 0 1 1 0 0 0 0 0 1 3
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Black or African American 0 0 0 1 0 0 1 0 0 0 0 0 0 2
White 3 1 10 2 2 2 5 10 1 15 2 15 3 71
More than one race 0 0 0 0 0 0 0 0 0 0 0 1 0 1
Unknown or Not Reported 0 0 1 0 0 0 0 0 0 3 0 0 1 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 1 participants 11 participants 3 participants 2 participants 3 participants 7 participants 10 participants 1 participants 18 participants 2 participants 16 participants 5 participants 82 participants
3 1 11 3 2 3 7 10 1 18 2 16 5 82
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 11 participants 3 participants 2 participants 3 participants 7 participants 10 participants 1 participants 18 participants 2 participants 16 participants 5 participants 82 participants
0 2 0 4 2 1 1 0 3 0 3 1 5 1 23
1 1 1 7 1 1 2 6 7 1 13 1 11 3 55
2 0 0 0 0 0 0 1 0 0 2 0 0 1 4
[1]
Measure Description: ECOGScale:Score-Description:0-Normalactivity.Fullyactive,abletocarryonallprediseaseperformancew/orestriction/1-Symptoms,but ambulatory.Restrictedinphysicallystrenuousactivity,butambulatoryandabletocarryoutworkofa light/sedentarynature(eg,light housework,office work)/2-In bed<50%ofthetime.Ambulatoryandcapableofallselfcare,but unabletocarryoutanyworkactivities.Upandabout>50%ofwakinghours/3-In bed>50%ofthetime.Capableofonlylimitedselfcare,confinedtobed/chair>50%ofwakinghours/4-100% bedridden.Completelydisabled.Cannotcarryonanyselfcare.Totallyconfinedtobed/chair/5-Dead.
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine
Hide Description MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).
Time Frame The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug.
Arm/Group Title Rovalpituzumab Tesirine
Hide Arm/Group Description:
Rovalpituzumab tesirine (SC16LD6.5) will be administered intravenously (IV) to subjects with recurrent small cell lung cancer. Rovalpituzumab tesirine will be given on Day 1 of every 21-day or 42-day cycle.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: mg/kg
0.4
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description

Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR).

Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).

Time Frame From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one post-dose assessment. All LCNEC subjects were analyzed. No LCNEC subjects achieved CR or PR and, therefore, the ORR was 0%.
Arm/Group Title SCLC Subjects LCNEC Subjects
Hide Arm/Group Description:
SCLC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
ORR unconfirmed by Investigator
25
(14.98 to 38.44)
0
(0 to 36.94)
ORR confirmed by Investigator
17
(8.44 to 28.97)
0
(0 to 36.94)
ORR unconfirmed by IRC
27
(16.14 to 40.96)
0
(0 to 39.94)
ORR confirmed by IRC
16
(7.77 to 28.8)
0
(0 to 36.94)
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description

Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first.

Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).

Time Frame From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one post-dose assessment. No LCNEC subjects achieved CR or PR, therefore DOR was not analyzed.
Arm/Group Title SCLC Subjects LCNEC Subjects
Hide Arm/Group Description:
SCLC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
Overall Number of Participants Analyzed 67 0
Median (95% Confidence Interval)
Unit of Measure: months
DOR by INV
2.89
(2.17 to 6.51)
DOR by IRC
1.71
(0.03 to 3.06)
4.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description

Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders.

Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).

Time Frame From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one post-dose assessment.
Arm/Group Title SCLC Subjects LCNEC Subjects
Hide Arm/Group Description:
SCLC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
Overall Number of Participants Analyzed 67 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
CBR unconfirmed by INV
73
(59.73 to 83.64)
88
(47.35 to 99.68)
CBR confirmed by INV
58
(44.07 to 70.39)
75
(34.91 to 96.81)
CBR unconfirmed by IRC
75
(61 to 85.33)
75
(34.91 to 96.81)
CBR confirmed by IRC
56
(42.32 to 69.7)
75
(34.91 to 96.81)
5.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study.

Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).

Time Frame From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one post-dose assessment.
Arm/Group Title SCLC Subjects LCNEC Subjects
Hide Arm/Group Description:
SCLC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
Overall Number of Participants Analyzed 67 8
Median (95% Confidence Interval)
Unit of Measure: months
PFS by INV
2.79
(2.33 to 3.71)
3.07
(1.45 to 6.83)
PFS by IRC
2.89
(2.14 to 3.84)
2.6
(1.25 to 14.46)
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive.
Time Frame From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one post-dose assessment.
Arm/Group Title SCLC Subjects LCNEC Subjects
Hide Arm/Group Description:
SCLC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
LCNEC Subjects who received rovalpituzumab tesirine 0.2 mg/kg to 0.4 mg/kg
Overall Number of Participants Analyzed 67 8
Median (95% Confidence Interval)
Unit of Measure: months
4.76
(4.01 to 7.13)
6.59
(2.89 to 14.46)
7.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC)
Hide Description The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle.
Time Frame From Day 1 of first dose to End of Dose Cycle
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.
Arm/Group Title Phase 1a: Cohort 1 Phase 1a: Cohort 2 Phase 1a: Cohort 3 Phase 1a: Cohort 4 Phase 1a: Cohort 5 Phase 1a: Cohort 6 Phase 1a: Cohort 7 Phase 1a: Cohort 8
Hide Arm/Group Description:
All Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
Overall Number of Participants Analyzed 3 1 10 3 2 3 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
1.27
(13%)
2.42
5.08
(21%)
8.81
(7%)
18.8
(27%)
11.4
(27%)
7.67
(21%)
5.36
(26%)
8.Secondary Outcome
Title Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC
Hide Description The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum.
Time Frame From Day 1 of first dose to End of Dose Cycle
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.
Arm/Group Title Phase 1a: Cohort 1 Phase 1a: Cohort 2 Phase 1a: Cohort 3 Phase 1a: Cohort 4 Phase 1a: Cohort 5 Phase 1a: Cohort 6 Phase 1a: Cohort 7 Phase 1a: Cohort 8
Hide Arm/Group Description:
All Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle
All Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle
All Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle
All Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle
Overall Number of Participants Analyzed 3 1 10 3 2 3 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg•d/mL
12.3
(22%)
26.3
45.6
(32%)
97.3
(21%)
142
(18%)
107
(28%)
64.8
(36%)
45.0
(34%)
Time Frame From date of first dose through 30-days following last dose (on average 85 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1a: Cohort 1 (SCLC) Phase 1a: Cohort 2 (SCLC) Phase 1a: Cohort 3 (SCLC) Phase 1a: Cohort 4 (SCLC) Phase 1a: Cohort 5 (SCLC) Phase 1a: Cohort 6 (SCLC) Phase 1a: Cohort 7 (SCLC) Phase 1a: Cohort 8 (SCLC) Phase 1a: Cohort 8 (LCNEC) Phase 1b: Retreatment (SCLC) Phase 1b: Retreatment (LCNEC) Phase 1b: Maintenance (SCLC) Phase 1b: Maintenance (LCNEC)
Hide Arm/Group Description SCLC Subjects: Rovalpituzumab tesirine 0.05 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.8 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.4 mg/kg on Day 1 of every 42-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle LCNEC Subjects: Rovalpituzumab tesirine 0.2 mg/kg on Day 1 of every 21-day cycle SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. Ongoing subjects from Phase 1a who received an initial dose of 0.2 mg/kg on Day 1 of each 21-day cycle for 3 cycles, and if eligible, retreatment with rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles. SCLC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle LCNEC Subjects: Rovalpituzumab tesirine 0.3 mg/kg on Day 1 of every 42-day cycle for 2 cycles; followed by maintenance with rovalpituzumab tesirine 0.1 mg/kg on Day 1 of every 42-day cycle
All-Cause Mortality
Phase 1a: Cohort 1 (SCLC) Phase 1a: Cohort 2 (SCLC) Phase 1a: Cohort 3 (SCLC) Phase 1a: Cohort 4 (SCLC) Phase 1a: Cohort 5 (SCLC) Phase 1a: Cohort 6 (SCLC) Phase 1a: Cohort 7 (SCLC) Phase 1a: Cohort 8 (SCLC) Phase 1a: Cohort 8 (LCNEC) Phase 1b: Retreatment (SCLC) Phase 1b: Retreatment (LCNEC) Phase 1b: Maintenance (SCLC) Phase 1b: Maintenance (LCNEC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Phase 1a: Cohort 1 (SCLC) Phase 1a: Cohort 2 (SCLC) Phase 1a: Cohort 3 (SCLC) Phase 1a: Cohort 4 (SCLC) Phase 1a: Cohort 5 (SCLC) Phase 1a: Cohort 6 (SCLC) Phase 1a: Cohort 7 (SCLC) Phase 1a: Cohort 8 (SCLC) Phase 1a: Cohort 8 (LCNEC) Phase 1b: Retreatment (SCLC) Phase 1b: Retreatment (LCNEC) Phase 1b: Maintenance (SCLC) Phase 1b: Maintenance (LCNEC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/1 (0.00%)   3/11 (27.27%)   3/3 (100.00%)   2/2 (100.00%)   2/3 (66.67%)   1/7 (14.29%)   4/10 (40.00%)   1/1 (100.00%)   7/18 (38.89%)   1/2 (50.00%)   5/16 (31.25%)   4/5 (80.00%) 
Blood and lymphatic system disorders                           
Thrombocytopenia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Pancytopenia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Cardiac disorders                           
Cardiac Tamponade  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  0/5 (0.00%) 
Pericardial Effusion  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders                           
Abdominal Pain  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Anal Fistula  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Dysphagia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Ascites  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Diarrhoea  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
General disorders                           
Asthenia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Fatigue  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Oedema Peripheral  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Pain  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Hepatobiliary disorders                           
Bile Duct Stenosis  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Cholelithiasis  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Infections and infestations                           
Pneumonia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Injury, poisoning and procedural complications                           
Fall  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Overdose  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Investigations                           
Liver Function Test Abnormal  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Blood Alkaline Phosphatase Increase  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders                           
Dehydration  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Hypoalbuminaemia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Hypokalaemia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  1/1 (100.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                           
Tumor Haemorrhage  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Nervous system disorders                           
Cauda Equina Syndrome  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Psychiatric disorders                           
Confusional State  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Psychotic Disorder  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders                           
Pleural Effusion  1  0/3 (0.00%)  0/1 (0.00%)  2/11 (18.18%)  1/3 (33.33%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  1/2 (50.00%)  2/16 (12.50%)  1/5 (20.00%) 
Dyspnoea  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  1/1 (100.00%)  3/18 (16.67%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Haemoptysis  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Pneumonia Aspiration  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Vascular disorders                           
Hypotension  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Capillary Leak Syndrome  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Thrombosis  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1a: Cohort 1 (SCLC) Phase 1a: Cohort 2 (SCLC) Phase 1a: Cohort 3 (SCLC) Phase 1a: Cohort 4 (SCLC) Phase 1a: Cohort 5 (SCLC) Phase 1a: Cohort 6 (SCLC) Phase 1a: Cohort 7 (SCLC) Phase 1a: Cohort 8 (SCLC) Phase 1a: Cohort 8 (LCNEC) Phase 1b: Retreatment (SCLC) Phase 1b: Retreatment (LCNEC) Phase 1b: Maintenance (SCLC) Phase 1b: Maintenance (LCNEC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   1/1 (100.00%)   11/11 (100.00%)   3/3 (100.00%)   2/2 (100.00%)   3/3 (100.00%)   7/7 (100.00%)   10/10 (100.00%)   1/1 (100.00%)   18/18 (100.00%)   2/2 (100.00%)   15/16 (93.75%)   5/5 (100.00%) 
Blood and lymphatic system disorders                           
Anaemia  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  1/7 (14.29%)  4/10 (40.00%)  0/1 (0.00%)  5/18 (27.78%)  1/2 (50.00%)  4/16 (25.00%)  1/5 (20.00%) 
Thrombocytopenia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  2/2 (100.00%)  0/3 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  1/1 (100.00%)  3/18 (16.67%)  0/2 (0.00%)  4/16 (25.00%)  2/5 (40.00%) 
Cardiac disorders                           
Pericardial Effusion  1  1/3 (33.33%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  1/2 (50.00%)  2/16 (12.50%)  0/5 (0.00%) 
Sinus Tachycardia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  2/7 (28.57%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  0/5 (0.00%) 
Eye disorders                           
Vision Blurred  1  1/3 (33.33%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  5/18 (27.78%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Periorbital Oedema  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  1/2 (50.00%)  4/16 (25.00%)  0/5 (0.00%) 
Lacrimation Increased  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders                           
Nausea  1  1/3 (33.33%)  0/1 (0.00%)  1/11 (9.09%)  3/3 (100.00%)  2/2 (100.00%)  0/3 (0.00%)  1/7 (14.29%)  4/10 (40.00%)  0/1 (0.00%)  8/18 (44.44%)  0/2 (0.00%)  3/16 (18.75%)  2/5 (40.00%) 
Constipation  1  1/3 (33.33%)  0/1 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/2 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  3/10 (30.00%)  0/1 (0.00%)  8/18 (44.44%)  1/2 (50.00%)  3/16 (18.75%)  2/5 (40.00%) 
Vomiting  1  2/3 (66.67%)  0/1 (0.00%)  2/11 (18.18%)  2/3 (66.67%)  2/2 (100.00%)  0/3 (0.00%)  2/7 (28.57%)  2/10 (20.00%)  0/1 (0.00%)  4/18 (22.22%)  1/2 (50.00%)  2/16 (12.50%)  1/5 (20.00%) 
Diarrhoea  1  2/3 (66.67%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  2/10 (20.00%)  0/1 (0.00%)  4/18 (22.22%)  1/2 (50.00%)  3/16 (18.75%)  1/5 (20.00%) 
Abdominal Pain  1  1/3 (33.33%)  0/1 (0.00%)  0/11 (0.00%)  2/3 (66.67%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  2/10 (20.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  0/16 (0.00%)  2/5 (40.00%) 
Abdominal Distension  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  1/16 (6.25%)  3/5 (60.00%) 
Dyspepsia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  2/16 (12.50%)  0/5 (0.00%) 
Dysphagia  1  0/3 (0.00%)  1/1 (100.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
General disorders                           
Fatigue  1  2/3 (66.67%)  0/1 (0.00%)  3/11 (27.27%)  2/3 (66.67%)  2/2 (100.00%)  3/3 (100.00%)  2/7 (28.57%)  6/10 (60.00%)  0/1 (0.00%)  12/18 (66.67%)  1/2 (50.00%)  5/16 (31.25%)  5/5 (100.00%) 
Oedema Peripheral  1  2/3 (66.67%)  0/1 (0.00%)  4/11 (36.36%)  0/3 (0.00%)  0/2 (0.00%)  2/3 (66.67%)  1/7 (14.29%)  2/10 (20.00%)  0/1 (0.00%)  7/18 (38.89%)  1/2 (50.00%)  6/16 (37.50%)  3/5 (60.00%) 
Pyrexia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  1/2 (50.00%)  1/3 (33.33%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  4/18 (22.22%)  0/2 (0.00%)  4/16 (25.00%)  1/5 (20.00%) 
Asthenia  1  1/3 (33.33%)  0/1 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/2 (0.00%)  1/3 (33.33%)  1/7 (14.29%)  1/10 (10.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Face Oedema  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  2/16 (12.50%)  0/5 (0.00%) 
Pain  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  2/10 (20.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Chills  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  1/5 (20.00%) 
Chest Pain  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  1/2 (50.00%)  0/16 (0.00%)  1/5 (20.00%) 
Infections and infestations                           
Upper Respiratory Tract Infection  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Pneumonia  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Urinary Tract Infection  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications                           
Fall  1  1/3 (33.33%)  0/1 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Investigations                           
Lipase Increased  1  0/3 (0.00%)  0/1 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  1/7 (14.29%)  1/10 (10.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  2/16 (12.50%)  1/5 (20.00%) 
Aspartate Aminotransferase Increased  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Blood Alkaline Phosphatase Increased  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  0/16 (0.00%)  2/5 (40.00%) 
Amylase Increased  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Blood Albumin Decreased  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  1/16 (6.25%)  1/5 (20.00%) 
Weight Increased  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  2/16 (12.50%)  1/5 (20.00%) 
Weight Decreased  1  1/3 (33.33%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  1/1 (100.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Alanine Aminotransferase Increased  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Metabolism and nutrition disorders                           
Decreased Appetite  1  2/3 (66.67%)  0/1 (0.00%)  0/11 (0.00%)  2/3 (66.67%)  1/2 (50.00%)  2/3 (66.67%)  3/7 (42.86%)  0/10 (0.00%)  1/1 (100.00%)  4/18 (22.22%)  0/2 (0.00%)  6/16 (37.50%)  3/5 (60.00%) 
Hypoalbuminaemia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  6/18 (33.33%)  1/2 (50.00%)  5/16 (31.25%)  2/5 (40.00%) 
Hypokalaemia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  1/1 (100.00%)  3/18 (16.67%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Dehydration  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  2/3 (66.67%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Hyperglycaemia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  1/1 (100.00%)  3/18 (16.67%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders                           
Arthralgia  1  1/3 (33.33%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  2/2 (100.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  3/18 (16.67%)  1/2 (50.00%)  7/16 (43.75%)  2/5 (40.00%) 
Back Pain  1  2/3 (66.67%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/1 (0.00%)  4/18 (22.22%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Pain in Extremity  1  0/3 (0.00%)  0/1 (0.00%)  2/11 (18.18%)  1/3 (33.33%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Myalgia  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  3/16 (18.75%)  1/5 (20.00%) 
Muscular Weakness  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  3/18 (16.67%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Musculoskeletal Chest Pain  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Neck Pain  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Nervous system disorders                           
Dizziness  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/2 (0.00%)  2/3 (66.67%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  4/16 (25.00%)  0/5 (0.00%) 
Headache  1  1/3 (33.33%)  1/1 (100.00%)  2/11 (18.18%)  1/3 (33.33%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Dysgeusia  1  1/3 (33.33%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Psychiatric disorders                           
Insomnia  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  1/1 (100.00%)  1/18 (5.56%)  0/2 (0.00%)  3/16 (18.75%)  1/5 (20.00%) 
Confusional State  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  3/10 (30.00%)  0/1 (0.00%)  0/18 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Anxiety  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  1/2 (50.00%)  2/16 (12.50%)  1/5 (20.00%) 
Depression  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders                           
Dyspnoea  1  1/3 (33.33%)  0/1 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/7 (0.00%)  2/10 (20.00%)  1/1 (100.00%)  10/18 (55.56%)  1/2 (50.00%)  4/16 (25.00%)  1/5 (20.00%) 
Pleural Effusion  1  1/3 (33.33%)  0/1 (0.00%)  3/11 (27.27%)  2/3 (66.67%)  0/2 (0.00%)  2/3 (66.67%)  2/7 (28.57%)  2/10 (20.00%)  0/1 (0.00%)  3/18 (16.67%)  1/2 (50.00%)  3/16 (18.75%)  1/5 (20.00%) 
Cough  1  1/3 (33.33%)  0/1 (0.00%)  2/11 (18.18%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  4/18 (22.22%)  0/2 (0.00%)  3/16 (18.75%)  3/5 (60.00%) 
Productive Cough  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  1/1 (100.00%)  2/18 (11.11%)  0/2 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Nasal Congestion  1  0/3 (0.00%)  0/1 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Sinus Congestion  1  0/3 (0.00%)  1/1 (100.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Epistaxis  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  1/5 (20.00%) 
Oropharyngeal Pain  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  1/16 (6.25%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders                           
Rash Maculo-papular  1  1/3 (33.33%)  0/1 (0.00%)  4/11 (36.36%)  1/3 (33.33%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  3/16 (18.75%)  1/5 (20.00%) 
Photosensitivity Reaction  1  0/3 (0.00%)  0/1 (0.00%)  2/11 (18.18%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  6/16 (37.50%)  2/5 (40.00%) 
Erythema  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  1/3 (33.33%)  1/2 (50.00%)  0/3 (0.00%)  2/7 (28.57%)  1/10 (10.00%)  0/1 (0.00%)  2/18 (11.11%)  1/2 (50.00%)  2/16 (12.50%)  1/5 (20.00%) 
Dry Skin  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  2/3 (66.67%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  5/18 (27.78%)  0/2 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Erythema Multiforme  1  1/3 (33.33%)  0/1 (0.00%)  3/11 (27.27%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  0/5 (0.00%) 
Dermatitis Acneiform  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Skin Exfoliation  1  0/3 (0.00%)  0/1 (0.00%)  1/11 (9.09%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  2/16 (12.50%)  0/5 (0.00%) 
Swelling Face  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  1/18 (5.56%)  0/2 (0.00%)  2/16 (12.50%)  1/5 (20.00%) 
Skin Hyperpigmentation  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  0/16 (0.00%)  2/5 (40.00%) 
Vascular disorders                           
Hypotension  1  0/3 (0.00%)  0/1 (0.00%)  0/11 (0.00%)  1/3 (33.33%)  1/2 (50.00%)  0/3 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/1 (0.00%)  2/18 (11.11%)  0/2 (0.00%)  1/16 (6.25%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Senior Director, Clinical Operations
Organization: AbbVie Stemcentrx
Phone: (650) 827-4879
EMail: isobel.lakatos@abbvie.com
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Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT01901653    
Other Study ID Numbers: SCRX16-001
First Submitted: July 11, 2013
First Posted: July 17, 2013
Results First Submitted: February 6, 2018
Results First Posted: July 11, 2018
Last Update Posted: August 9, 2018