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A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02202746
Recruitment Status : Terminated (Sponsor decision to end monotherapy development of the compound in breast cancer.)
First Posted : July 29, 2014
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Metastatic Breast Cancer
MBC
HER2 Positive
HER2
Estrogen Receptor Positive
ER
Triple Negative
Intervention Drug: Lucitanib
Enrollment 178
Recruitment Details 178 patients were recruited from 32 sites in the United States.
Pre-assignment Details  
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description 10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons 15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
Period Title: Overall Study
Started 109 69
Completed 109 69
Not Completed 0 0
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD Total
Hide Arm/Group Description 10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons 15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons Total of all reporting groups
Overall Number of Baseline Participants 109 69 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 109 participants 69 participants 178 participants
57.0
(27 to 82)
53.0
(27 to 80)
55.0
(27 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 69 participants 178 participants
Female
109
 100.0%
67
  97.1%
176
  98.9%
Male
0
   0.0%
2
   2.9%
2
   1.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 69 participants 178 participants
White
87
  79.8%
61
  88.4%
148
  83.1%
Asian
5
   4.6%
3
   4.3%
8
   4.5%
Black
10
   9.2%
1
   1.4%
11
   6.2%
Not provided
4
   3.7%
3
   4.3%
7
   3.9%
Unknown/Not assessed
2
   1.8%
1
   1.4%
3
   1.7%
Other
1
   0.9%
0
   0.0%
1
   0.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 69 participants 178 participants
Hispanic or Latino
8
   7.3%
6
   8.7%
14
   7.9%
Not Hispanic or Latino
97
  89.0%
61
  88.4%
158
  88.8%
Not Provided
4
   3.7%
2
   2.9%
6
   3.4%
Number of Prior Anticancer Therapies  
Median (Full Range)
Unit of measure:  Therapies
Number Analyzed 109 participants 69 participants 178 participants
6.0
(1 to 18)
6.0
(1 to 16)
6.0
(1 to 18)
Fibroblast Growth Factor (FGF) Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 69 participants 178 participants
11q
34
  31.2%
25
  36.2%
59
  33.1%
FGFR1
50
  45.9%
28
  40.6%
78
  43.8%
FGFR1 & 11q
18
  16.5%
10
  14.5%
28
  15.7%
Negative
7
   6.4%
6
   8.7%
13
   7.3%
[1]
Measure Description: FGFR1 and 11q are genes that are amplified in a percentage of breast cancers. Sites were required to submit archival tumor specimens for all enrolled patients for central laboratory confirmation of FGFR1 or 11q amplification status. Patients were categorized based on results indicating FGFR1 amplification, 11q amplification, both FGFR1 and 11q amplification, or non-amplification of either gene (negative).
1.Primary Outcome
Title Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by the Investigator
Hide Description The primary efficacy endpoint of PFS was calculated as 1+ the number of days from the date of first dose of study drug to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment), or the date of randomization if no tumor assessments were performed. Progression events were determined by the investigator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population: all patients who have received at least one dose of lucitanib and are confirmed as FGR1-, 11q-amplified, or FGF non-amplified per the central laboratory
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
Overall Number of Participants Analyzed 107 67
Median (95% Confidence Interval)
Unit of Measure: Days
93
(78 to 140)
77
(50 to 86)
2.Secondary Outcome
Title Objective Response Rate (ORR) by RECIST v1.1
Hide Description ORR is the percentage of patients with a best response of CR or PR according to RECIST v1.1. The best response is recorded from the start of the treatment (Day 1) until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time Frame From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population: all patients who have received at least one dose of lucitanib and are confirmed as FGR1-, 11q-amplified, or FGF non-amplified per the central laboratory
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD All Patients
Hide Arm/Group Description:
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
The total efficacy population analyzed for response
Overall Number of Participants Analyzed 106 67 173
Measure Type: Number
Unit of Measure: percentage of participants
4.7 1.5 3.5
3.Secondary Outcome
Title Duration of Response (DR) by RECIST v1.1
Hide Description DR for complete response (CR) and partial response (PR) was measured from the date that any of these best confirmed responses was first recorded until the first date that PD was objectively documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time Frame From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population for patients who had a confirmed CR or PR
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
Overall Number of Participants Analyzed 5 1
Median (Full Range)
Unit of Measure: Days
175
(44 to 209)
336
(336 to 336)
4.Secondary Outcome
Title Disease Control Rate (DCR) by RECIST v1.1
Hide Description The DCR is defined as the percentage of patients with a best response rate of CR, PR, or SD for at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Time Frame From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population only
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD All Patients
Hide Arm/Group Description:
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
The total efficacy population analyzed for response
Overall Number of Participants Analyzed 106 67 173
Measure Type: Number
Unit of Measure: percentage of patients
48.1 34.3 42.8
5.Secondary Outcome
Title Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Cmax
Hide Description The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Cmax = maximum concentration following administration of lucitanib.
Time Frame Study Day -7 to Study Day 1, or approximately 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients (N=15)
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib tablet or capsule given orally
15 mg of lucitanib tablet or capsule given orally
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
Tablet 292  (156) 278  (99.8)
Capsule 265  (137) 285  (121)
6.Secondary Outcome
Title Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Tmax
Hide Description The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Tmax = time to maximum concentration following administration of lucitanib
Time Frame Study Day -7 to Study Day 1, or approximately 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients (N=15)
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib tablet or capsule given orally
15 mg of lucitanib tablet or capsule given orally
Overall Number of Participants Analyzed 9 6
Median (Full Range)
Unit of Measure: Hours
Tablet
1.0
(0.5 to 4.0)
1.0
(0.5 to 2.5)
Capsule
1.5
(1.0 to 4.0)
1.0
(1.0 to 2.5)
7.Secondary Outcome
Title Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUClast
Hide Description The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUClast = area under the plasma concentration time curve from time 0 to the last quantifiable time point (24 hour)
Time Frame Study Day -7 to Study Day 1, or approximately 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients (N=15)
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib tablet or capsule given orally
15 mg of lucitanib tablet or capsule given orally
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Tablet 2550  (1150) 2840  (1230)
Capsule 2650  (1380) 2420  (613)
8.Secondary Outcome
Title Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUCinf
Hide Description The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUCinf = area under the plasma concentration time curve from 0 to infinity
Time Frame Study Day -7 to Study Day 1, or approximately 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients (N=15)
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib tablet or capsule given orally
15 mg of lucitanib tablet or capsule given orally
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Tablet 4780  (2140) 5720  (3760)
Capsule 5680  (2730) 4620  (1620)
9.Secondary Outcome
Title Relative Bioavailability Analysis for Tablet vs Capsule - Cmax, AUClast, AUCinf
Hide Description Relative bioavailability of lucitanib was evaluated by comparison of (log-transformed) AUClast, Cmax and AUCinf of the tablet formulation to the capsule formulation using an analysis of variance (ANOVA) model with treatment as a fixed effect. The geometric means, ratio of the geometric means and 90% confidence intervals (CI) on the ratio of Tablet to Capsule (T:R) were presented for AUClast, Cmax and AUCinf. The CIs on the ratio of untransformed PK parameters were derived through reverse transformation of the 90% CI of the difference in the log scale to the 90% CI of the ratio in the original scale.
Time Frame Study Day -7 to Study Day 1, or approximately 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters were assessed in a subset of patients (N=15).
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description:
10 mg of lucitanib tablet or capsule given orally
15 mg of lucitanib tablet or capsule given orally
Overall Number of Participants Analyzed 9 6
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage (tablet/capsule)
Cmax Geometric Mean Ratio
111.73
(70.35 to 177.45)
100.56
(64.59 to 156.55)
AUClast Geometric Mean Ratio
97.58
(60.61 to 157.09)
112.2
(78.73 to 159.89)
AUCinf Geometric Mean Ratio
82.9
(51.75 to 132.81)
114.23
(70.09 to 186.15)
10.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.
Time Frame Cycle 1 Day 1 to date of death, assessed up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population by initial treatment and overall
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD All Patients
Hide Arm/Group Description:
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
The total efficacy population analyzed for response
Overall Number of Participants Analyzed 109 69 178
Median (95% Confidence Interval)
Unit of Measure: Months
15.0
(10.7 to 17.3)
7.7
(6.1 to 10.3)
10.7
(8.5 to 13.7)
11.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Total Score
Hide Description FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 37 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (10 items) ranging from 0 to 40; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. FACT-B Total Score is derived from adding the five subscale scores. Total possible score ranges from 0 to 148. High scale score represents a better QoL.
Time Frame From Cycle 1 Day 1 until end of treatment, assessed up to 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population defined as all patients who have received at least one dose of Lucitanib and have at least one post-baseline Investigator Overall Objective Tumor Assessment. 'Overall Number of Participants Analyzed'=participants who completed both a baseline FACT-B assessment and at least one post-baseline assessment.
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD All Patients
Hide Arm/Group Description:
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
The total efficacy population analyzed for response
Overall Number of Participants Analyzed 80 46 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.422  (15.5134) -7.586  (17.0709) -4.307  (16.2248)
Time Frame Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
Adverse Event Reporting Description If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
 
Arm/Group Title Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Hide Arm/Group Description 10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons 15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
All-Cause Mortality
Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   5/109 (4.59%)   7/69 (10.14%) 
Hide Serious Adverse Events
Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   31/109 (28.44%)   22/69 (31.88%) 
Blood and lymphatic system disorders     
Anaemia  1  0/109 (0.00%)  1/69 (1.45%) 
Febrile neutropenia  1  1/109 (0.92%)  0/69 (0.00%) 
Cardiac disorders     
Sinus bradycardia  1  0/109 (0.00%)  1/69 (1.45%) 
Sinus tachycardia  1  1/109 (0.92%)  0/69 (0.00%) 
Supraventricular tachycardia  1  1/109 (0.92%)  0/69 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  0/109 (0.00%)  1/69 (1.45%) 
Gastrointestinal disorders     
Abdominal pain  1  0/109 (0.00%)  1/69 (1.45%) 
Abdominal pain upper  1  0/109 (0.00%)  1/69 (1.45%) 
Diarrhoea  1  0/109 (0.00%)  1/69 (1.45%) 
Duodenal ulcer  1  0/109 (0.00%)  1/69 (1.45%) 
Dysphagia  1  2/109 (1.83%)  0/69 (0.00%) 
Gastrointestinal haemorrhage  1  1/109 (0.92%)  1/69 (1.45%) 
Nausea  1  1/109 (0.92%)  2/69 (2.90%) 
Small intestinal obstruction  1  0/109 (0.00%)  1/69 (1.45%) 
Tooth impacted  1  0/109 (0.00%)  1/69 (1.45%) 
Upper gastrointestinal haemorrhage  1  1/109 (0.92%)  0/69 (0.00%) 
Vomiting  1  0/109 (0.00%)  2/69 (2.90%) 
General disorders     
Mucosal inflammation  1  0/109 (0.00%)  1/69 (1.45%) 
Pyrexia  1  1/109 (0.92%)  0/69 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/109 (0.92%)  0/69 (0.00%) 
Infections and infestations     
Atypical pneumonia  1  1/109 (0.92%)  0/69 (0.00%) 
Cellulitis  1  1/109 (0.92%)  0/69 (0.00%) 
Pneumonia  1  2/109 (1.83%)  1/69 (1.45%) 
Urinary tract infection  1  1/109 (0.92%)  1/69 (1.45%) 
Investigations     
Alanine aminotransferase increased  1  1/109 (0.92%)  0/69 (0.00%) 
Ammonia increased  1  0/109 (0.00%)  1/69 (1.45%) 
Aspartate aminotransferase increased  1  1/109 (0.92%)  0/69 (0.00%) 
Blood bilirubin increased  1  1/109 (0.92%)  0/69 (0.00%) 
Platelet count decreased  1  0/109 (0.00%)  1/69 (1.45%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/109 (0.92%)  1/69 (1.45%) 
Hypomagnesaemia  1  1/109 (0.92%)  0/69 (0.00%) 
Hyponatraemia  1  3/109 (2.75%)  1/69 (1.45%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/109 (0.92%)  0/69 (0.00%) 
Bone pain  1  0/109 (0.00%)  1/69 (1.45%) 
Osteoarthritis  1  1/109 (0.92%)  0/69 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  5/109 (4.59%)  5/69 (7.25%) 
Malignant pleural effusion  1  0/109 (0.00%)  1/69 (1.45%) 
Nervous system disorders     
Aphasia  1  0/109 (0.00%)  1/69 (1.45%) 
Headache  1  2/109 (1.83%)  0/69 (0.00%) 
Migraine  1  1/109 (0.92%)  0/69 (0.00%) 
Psychiatric disorders     
Mental status changes  1  1/109 (0.92%)  0/69 (0.00%) 
Renal and urinary disorders     
Hydronephrosis  1  0/109 (0.00%)  1/69 (1.45%) 
Renal tubular acidosis  1  1/109 (0.92%)  0/69 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/109 (1.83%)  1/69 (1.45%) 
Dyspnoea exertional  1  0/109 (0.00%)  1/69 (1.45%) 
Hypoxia  1  1/109 (0.92%)  3/69 (4.35%) 
Lung infiltration  1  0/109 (0.00%)  1/69 (1.45%) 
Pleural effusion  1  2/109 (1.83%)  1/69 (1.45%) 
Pulmonary embolism  1  1/109 (0.92%)  1/69 (1.45%) 
Vascular disorders     
Hypertension  1  2/109 (1.83%)  2/69 (2.90%) 
Hypertensive crisis  1  1/109 (0.92%)  0/69 (0.00%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lucitanib (CO-3810) 10 mg QD Lucitanib (CO-3810) 15 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   107/109 (98.17%)   69/69 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  5/109 (4.59%)  6/69 (8.70%) 
Neutropenia  1  0/109 (0.00%)  4/69 (5.80%) 
Thrombocytopenia  1  8/109 (7.34%)  9/69 (13.04%) 
Endocrine disorders     
Hypothyroidism  1  41/109 (37.61%)  34/69 (49.28%) 
Eye disorders     
Vision blurred  1  7/109 (6.42%)  3/69 (4.35%) 
Gastrointestinal disorders     
Abdominal distension  1  9/109 (8.26%)  6/69 (8.70%) 
Abdominal pain  1  16/109 (14.68%)  9/69 (13.04%) 
Abdominal pain upper  1  5/109 (4.59%)  6/69 (8.70%) 
Constipation  1  20/109 (18.35%)  12/69 (17.39%) 
Diarrhoea  1  33/109 (30.28%)  19/69 (27.54%) 
Dry mouth  1  11/109 (10.09%)  5/69 (7.25%) 
Dyspepsia  1  10/109 (9.17%)  4/69 (5.80%) 
Nausea  1  53/109 (48.62%)  33/69 (47.83%) 
Vomiting  1  35/109 (32.11%)  24/69 (34.78%) 
General disorders     
Fatigue  1  55/109 (50.46%)  37/69 (53.62%) 
Mucosal inflammation  1  3/109 (2.75%)  4/69 (5.80%) 
Oedema peripheral  1  13/109 (11.93%)  4/69 (5.80%) 
Pain  1  7/109 (6.42%)  3/69 (4.35%) 
Pyrexia  1  8/109 (7.34%)  2/69 (2.90%) 
Infections and infestations     
Sinusitis  1  6/109 (5.50%)  1/69 (1.45%) 
Upper respiratory tract infection  1  4/109 (3.67%)  4/69 (5.80%) 
Urinary tract infection  1  14/109 (12.84%)  10/69 (14.49%) 
Investigations     
Alanine aminotransferase increased  1  9/109 (8.26%)  4/69 (5.80%) 
Aspartate aminotransferase increased  1  10/109 (9.17%)  4/69 (5.80%) 
Blood alkaline phosphatase increased  1  9/109 (8.26%)  3/69 (4.35%) 
Blood bilirubin increased  1  6/109 (5.50%)  4/69 (5.80%) 
Blood thyroid stimulating hormone increased  1  6/109 (5.50%)  2/69 (2.90%) 
Ejection fraction decreased  1  3/109 (2.75%)  5/69 (7.25%) 
Platelet count decreased  1  4/109 (3.67%)  6/69 (8.70%) 
Weight decreased  1  8/109 (7.34%)  5/69 (7.25%) 
Metabolism and nutrition disorders     
Decreased appetite  1  36/109 (33.03%)  21/69 (30.43%) 
Dehydration  1  8/109 (7.34%)  2/69 (2.90%) 
Hypokalaemia  1  9/109 (8.26%)  3/69 (4.35%) 
Hyponatraemia  1  9/109 (8.26%)  9/69 (13.04%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  13/109 (11.93%)  12/69 (17.39%) 
Back pain  1  18/109 (16.51%)  9/69 (13.04%) 
Muscular weakness  1  6/109 (5.50%)  2/69 (2.90%) 
Musculoskeletal chest pain  1  6/109 (5.50%)  5/69 (7.25%) 
Musculoskeletal pain  1  8/109 (7.34%)  2/69 (2.90%) 
Myalgia  1  3/109 (2.75%)  5/69 (7.25%) 
Neck pain  1  7/109 (6.42%)  1/69 (1.45%) 
Pain in extremity  1  5/109 (4.59%)  4/69 (5.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  5/109 (4.59%)  5/69 (7.25%) 
Nervous system disorders     
Dizziness  1  15/109 (13.76%)  5/69 (7.25%) 
Dysgeusia  1  5/109 (4.59%)  4/69 (5.80%) 
Headache  1  42/109 (38.53%)  24/69 (34.78%) 
Psychiatric disorders     
Anxiety  1  7/109 (6.42%)  6/69 (8.70%) 
Depression  1  8/109 (7.34%)  7/69 (10.14%) 
Insomnia  1  11/109 (10.09%)  6/69 (8.70%) 
Renal and urinary disorders     
Haematuria  1  3/109 (2.75%)  6/69 (8.70%) 
Proteinuria  1  22/109 (20.18%)  22/69 (31.88%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  19/109 (17.43%)  7/69 (10.14%) 
Dyspnoea  1  22/109 (20.18%)  14/69 (20.29%) 
Pleural effusion  1  4/109 (3.67%)  4/69 (5.80%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  6/109 (5.50%)  8/69 (11.59%) 
Rash  1  5/109 (4.59%)  6/69 (8.70%) 
Rash maculo-papular  1  1/109 (0.92%)  4/69 (5.80%) 
Vascular disorders     
Hot flush  1  5/109 (4.59%)  4/69 (5.80%) 
Hypertension  1  85/109 (77.98%)  50/69 (72.46%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
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.
All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Department
Organization: Clovis Oncology, Inc.
Phone: +1 415 409 7220
EMail: medinfo@clovisoncology.com
Layout table for additonal information
Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02202746    
Other Study ID Numbers: CO-3810-025
First Submitted: July 25, 2014
First Posted: July 29, 2014
Results First Submitted: February 20, 2020
Results First Posted: June 23, 2020
Last Update Posted: June 23, 2020