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A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas

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ClinicalTrials.gov Identifier: NCT00400764
Recruitment Status : Terminated
First Posted : November 17, 2006
Results First Posted : October 7, 2011
Last Update Posted : November 23, 2011
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Interventions Drug: Dulanermin
Drug: Rituximab
Enrollment 72
Recruitment Details The Phase Ib part of this study was completed prior to the start of Phase II. Phase Ib participants were not eligible for participation in Phase II.
Pre-assignment Details  
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Period Title: Phase Ib
Started 6 6 0 0 0
Treated 6 6 0 0 0
Completed 0 [1] 2 0 0 0
Not Completed 6 4 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Death             1             0             0             0             0
Disease Progression             4             4             0             0             0
[1]
One patient reported as discontinued due to an AE should have been reported as death.
Period Title: Phase II
Started 0 0 23 26 11
Treated 0 0 22 [1] 26 11
Completed 0 0 0 0 0
Not Completed 0 0 23 26 11
Reason Not Completed
Death             0             0             1             2             0
Lost to Follow-up             0             0             1             0             0
Physician Decision             0             0             1             1             0
Sponsor’s decision to terminate             0             0             18             22             11
Patient began new, non-protocol, therapy             0             0             1             0             0
Withdrawal by Subject             0             0             1             1             0
[1]
One patient in the Rituximab arm withdrew prior to treatment
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin Total
Hide Arm/Group Description Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Total of all reporting groups
Overall Number of Baseline Participants 6 6 22 26 11 71
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 22 participants 26 participants 11 participants 71 participants
56.3  (15.9) 63.7  (9.0) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 60.0  (12.9)
[1]
Measure Description: Age demographic data for the Phase Ib population.
[2]
Age demographic data for the Phase Ib population.
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 22 participants 26 participants 11 participants 71 participants
NA [2]   (NA) NA [2]   (NA) 58.0  (8.5) 58.4  (9.8) 61.4  (13.3) 58.8  (10.0)
[1]
Measure Description: Age demographic data for the Phase II population.
[2]
Age demographic data for the Phase II population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 22 participants 26 participants 11 participants 71 participants
Female
1
  16.7%
1
  16.7%
9
  40.9%
7
  26.9%
2
  18.2%
20
  28.2%
Male
5
  83.3%
5
  83.3%
13
  59.1%
19
  73.1%
9
  81.8%
51
  71.8%
1.Primary Outcome
Title Phase Ib: Number of Participants With a Dose-limiting Toxicity
Hide Description A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).
Time Frame The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window.
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
0 0
2.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events by Severity Grade
Hide Description Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE).
Time Frame From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 6 6 22 26 11
Measure Type: Number
Unit of Measure: participants
Grade 5 AE 0 0 1 0 0
Grade 4 AE 1 0 0 0 0
Grade 3 AE 1 3 1 6 0
Grade 2 AE 4 1 8 10 4
Grade 1 AE 0 2 6 7 4
Any Grade AEs 6 6 16 23 8
3.Primary Outcome
Title Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)
Hide Description

Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment.

Patients without a post-baseline tumor assessment were considered non-responders.

Time Frame From Baseline through Study Termination (up to approximately 33 months)
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Hide Analysis Population Description
The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF.
Arm/Group Title Rituximab Combination Therapy Dulanermin
Hide Arm/Group Description:
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 22 25 11
Measure Type: Number
Unit of Measure: participants
Total Objective Response 14 16 1
Complete Response 5 3 0
Complete Response unconfirmed 0 2 0
Partial Response 9 11 1
4.Primary Outcome
Title Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit
Hide Description Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.
Time Frame Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 6 6 22 26 11
Mean (Standard Deviation)
Unit of Measure: mmHg
Diastolic Blood Pressure -8.7  (10.9) -5.2  (7.9) 2.3  (9.9) 1.6  (9.2) -0.8  (5.6)
Systolic Blood Pressure -3.2  (16.8) -4.7  (10.9) -3.4  (14.8) -2.2  (19.6) -4.2  (9.5)
5.Primary Outcome
Title Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit
Hide Description Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.
Time Frame Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 6 6 22 26 11
Mean (Standard Deviation)
Unit of Measure: beats/minute
7.0  (21.4) -1.5  (6.7) 0.5  (9.6) 3.3  (10.6) 5.0  (13.2)
6.Primary Outcome
Title Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit
Hide Description Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement.
Time Frame Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 6 6 22 26 11
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
-0.0  (0.6) -0.3  (0.7) 2.8  (13.1) -0.1  (0.4) 0.0  (0.4)
7.Primary Outcome
Title Number of Participants With a Clinically Significant Laboratory Abnormality
Hide Description Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0.
Time Frame Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug.
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 6 6 22 26 11
Measure Type: Number
Unit of Measure: participants
3 4 5 11 5
8.Primary Outcome
Title Mean Serum Concentration of Dulanermin
Hide Description The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA).
Time Frame Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety-evaluable population
Arm/Group Title Phase Ib Dulanermin Phase II Dulanermin
Hide Arm/Group Description:
Participants received 4.0 mg/kg/day or 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants may also have received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Overall Number of Participants Analyzed 12 43
Mean (Standard Deviation)
Unit of Measure: µg/ml
30 minutes after the start of infusion 0.109  (0.37) 0.001  (0.00)
1.5 hours after the start of infusion 40.4  (19.03) 51.5  (14.00)
2 hours after the start of infusion 49.9  (32.04) 79.8  (22.54)
3 hours after the start of infusion 29.5  (20.75) 28.7  (10.13)
5 hours after the start of infusion 2.21  (1.87) 9.89  (21.86)
7 hours after the start of infusion 4.89  (15.69) 0.445  (0.26)
24 hours after the start of infusion 0.324  (0.66) 0.002  (0.00)
9.Secondary Outcome
Title Phase II: Progression Free Survival
Hide Description Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan−Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment.
Time Frame From Baseline through Study Termination (up to approximately 33 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment
Arm/Group Title Rituximab Combination Therapy Dulanermin
Hide Arm/Group Description:
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 22 26 11
Median (95% Confidence Interval)
Unit of Measure: months
29.9
(9.2 to 29.9)
17.9
(9.9 to 18.4)
6.9 [1] 
(2.9 to NA)
[1]
The upper limit of the confidence interval was not estimable due to low numbers of events.
10.Secondary Outcome
Title Phase II: Overall Survival
Hide Description Median overall survival could not be estimated because of the low number of deaths at the time of study termination.
Time Frame From Baseline through Study Termination (up to approximately 33 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Combination Therapy Dulanermin
Hide Arm/Group Description:
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Phase II: Objective Response as Assessed by the Investigator
Hide Description Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders.
Time Frame From Baseline through Study Termination (up to approximately 33 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.
Arm/Group Title Rituximab Combination Therapy Dulanermin
Hide Arm/Group Description:
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 22 26 11
Measure Type: Number
Unit of Measure: participants
Total Objective Response 15 17 1
Complete Response 7 7 1
Complete Response unconfirmed 0 1 0
Partial Response 8 9 0
12.Secondary Outcome
Title Phase II: Duration of Response as Assessed by the Investigator
Hide Description

An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study.

Kaplan−Meier methods were used to estimate median, percentiles, and range of duration of response.

Time Frame From Baseline through Study Termination (up to approximately 33 months)
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Hide Analysis Population Description
Safety-evaluable patients with an objective response determined by the Investigator.
Arm/Group Title Rituximab Combination Therapy Dulanermin
Hide Arm/Group Description:
Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Overall Number of Participants Analyzed 15 17 1
Median (95% Confidence Interval)
Unit of Measure: months
21.4
(7.7 to 21.4)
11.3 [1] 
(8.0 to NA)
NA [2] 
(NA to NA)
[1]
Could not be calculated due to low number of patients with events.
[2]
Median duration of objective response could not be estimated for the dulanermin only arm because only 1 patient had an objective response based on investigator assessment
Time Frame Adverse events occurring on or after the first treatment through Study Termination (up to approximately 13 months for phase Ib and up to approximately 33 months for phase II) are summarized.
Adverse Event Reporting Description Evaluation is on all Treated Patients.
 
Arm/Group Title Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Hide Arm/Group Description Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses. Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
All-Cause Mortality
Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   1/6 (16.67%)   1/22 (4.55%)   4/26 (15.38%)   0/11 (0.00%) 
Gastrointestinal disorders           
ABDOMINAL PAIN  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
CONSTIPATION  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
ILEUS PARALYTIC  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
General disorders           
INFUSION RELATED REACTION  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
Infections and infestations           
PNEUMONIA  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
SEPSIS  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
MYELODYSPLASTIC SYNDROME  1  0/6 (0.00%)  0/6 (0.00%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase Ib - Dulanermin 4 mg/kg Phase Ib - Dulanermin 8 mg/kg Phase II - Rituximab Phase II - Combination Therapy Phase II - Dulanermin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   16/22 (72.73%)   22/26 (84.62%)   8/11 (72.73%) 
Blood and lymphatic system disorders           
ANAEMIA  1  1/6 (16.67%)  0/6 (0.00%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
COAGULOPATHY  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
DISSEMINATED INTRAVASCULAR COAGULATION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
NEUTROPENIA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
THROMBOCYTOPENIA  1  1/6 (16.67%)  0/6 (0.00%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
Cardiac disorders           
LEFT VENTRICULAR DYSFUNCTION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
RIGHT VENTRICULAR DYSFUNCTION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Ear and labyrinth disorders           
DEAFNESS UNILATERAL  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Endocrine disorders           
ADRENAL INSUFFICIENCY  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Eye disorders           
DRY EYE  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
VISION BLURRED  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  1/11 (9.09%) 
Gastrointestinal disorders           
DIARRHOEA  1  2/6 (33.33%)  2/6 (33.33%)  2/22 (9.09%)  2/26 (7.69%)  0/11 (0.00%) 
NAUSEA  1  2/6 (33.33%)  2/6 (33.33%)  4/22 (18.18%)  4/26 (15.38%)  0/11 (0.00%) 
VOMITING  1  2/6 (33.33%)  1/6 (16.67%)  3/22 (13.64%)  3/26 (11.54%)  0/11 (0.00%) 
ABDOMINAL PAIN UPPER  1  2/6 (33.33%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
CONSTIPATION  1  0/6 (0.00%)  2/6 (33.33%)  1/22 (4.55%)  4/26 (15.38%)  0/11 (0.00%) 
ABDOMINAL DISCOMFORT  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
DYSPHAGIA  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
ORAL PAIN  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
SENSITIVITY OF TEETH  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
STOMATITIS  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
TOOTHACHE  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
ABDOMINAL PAIN  1  0/6 (0.00%)  0/6 (0.00%)  2/22 (9.09%)  2/26 (7.69%)  0/11 (0.00%) 
HAEMORRHOIDS  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  1/11 (9.09%) 
General disorders           
FATIGUE  1  6/6 (100.00%)  3/6 (50.00%)  2/22 (9.09%)  3/26 (11.54%)  3/11 (27.27%) 
CHILLS  1  1/6 (16.67%)  3/6 (50.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
PYREXIA  1  2/6 (33.33%)  1/6 (16.67%)  0/22 (0.00%)  5/26 (19.23%)  0/11 (0.00%) 
CATHETER SITE PAIN  1  2/6 (33.33%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
CHEST PAIN  1  2/6 (33.33%)  0/6 (0.00%)  1/22 (4.55%)  1/26 (3.85%)  0/11 (0.00%) 
CATHETER SITE ERYTHEMA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
CATHETER SITE PRURITUS  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
FEELING COLD  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
GAIT DISTURBANCE  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
MUCOSAL INFLAMMATION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
OEDEMA PERIPHERAL  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
PAIN  1  0/6 (0.00%)  1/6 (16.67%)  1/22 (4.55%)  1/26 (3.85%)  0/11 (0.00%) 
SWELLING  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
ASTHENIA  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  4/26 (15.38%)  2/11 (18.18%) 
HERNIA  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  1/11 (9.09%) 
Hepatobiliary disorders           
HEPATIC FAILURE  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Immune system disorders           
DRUG HYPERSENSITIVITY  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  2/26 (7.69%)  0/11 (0.00%) 
Infections and infestations           
UPPER RESPIRATORY TRACT INFECTION  1  2/6 (33.33%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
GROIN INFECTION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
HERPES ZOSTER  1  1/6 (16.67%)  0/6 (0.00%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
PNEUMONIA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
ORAL HERPES  1  0/6 (0.00%)  0/6 (0.00%)  1/22 (4.55%)  4/26 (15.38%)  0/11 (0.00%) 
VIRAL INFECTION  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  2/11 (18.18%) 
RHINITIS  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  1/11 (9.09%) 
Injury, poisoning and procedural complications           
CONTUSION  1  0/6 (0.00%)  1/6 (16.67%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
INCISION SITE PAIN  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Investigations           
LIPASE INCREASED  1  1/6 (16.67%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
BACTERIAL TEST POSITIVE  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
BLOOD AMYLASE INCREASED  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Metabolism and nutrition disorders           
DECREASED APPETITE  1  3/6 (50.00%)  1/6 (16.67%)  2/22 (9.09%)  0/26 (0.00%)  0/11 (0.00%) 
HYPERKALAEMIA  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
HYPOMAGNESAEMIA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
METABOLIC ACIDOSIS  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
FLUID RETENTION  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders           
ARTHRALGIA  1  3/6 (50.00%)  0/6 (0.00%)  4/22 (18.18%)  0/26 (0.00%)  0/11 (0.00%) 
PAIN IN EXTREMITY  1  1/6 (16.67%)  1/6 (16.67%)  0/22 (0.00%)  2/26 (7.69%)  0/11 (0.00%) 
MUSCULOSKELETAL PAIN  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  1/26 (3.85%)  0/11 (0.00%) 
Nervous system disorders           
HEADACHE  1  1/6 (16.67%)  1/6 (16.67%)  1/22 (4.55%)  4/26 (15.38%)  0/11 (0.00%) 
PARAESTHESIA  1  0/6 (0.00%)  2/6 (33.33%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
SINUS HEADACHE  1  0/6 (0.00%)  2/6 (33.33%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
TREMOR  1  1/6 (16.67%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
DIZZINESS  1  0/6 (0.00%)  1/6 (16.67%)  1/22 (4.55%)  0/26 (0.00%)  1/11 (9.09%) 
DYSGEUSIA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
HYPOGEUSIA  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
NEUROPATHY PERIPHERAL  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  2/26 (7.69%)  0/11 (0.00%) 
Psychiatric disorders           
ANXIETY  1  0/6 (0.00%)  1/6 (16.67%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
INSOMNIA  1  1/6 (16.67%)  0/6 (0.00%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
NERVOUSNESS  1  0/6 (0.00%)  1/6 (16.67%)  1/22 (4.55%)  0/26 (0.00%)  0/11 (0.00%) 
Renal and urinary disorders           
NOCTURIA  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
RENAL FAILURE ACUTE  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
OROPHARYNGEAL PAIN  1  1/6 (16.67%)  2/6 (33.33%)  3/22 (13.64%)  1/26 (3.85%)  0/11 (0.00%) 
COUGH  1  1/6 (16.67%)  1/6 (16.67%)  3/22 (13.64%)  2/26 (7.69%)  0/11 (0.00%) 
SINUS CONGESTION  1  1/6 (16.67%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
DYSPNOEA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  2/26 (7.69%)  1/11 (9.09%) 
HYPOXIA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
LUNG CONSOLIDATION  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
PRODUCTIVE COUGH  1  1/6 (16.67%)  0/6 (0.00%)  1/22 (4.55%)  1/26 (3.85%)  0/11 (0.00%) 
RESPIRATORY DISTRESS  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
RESPIRATORY TRACT CONGESTION  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
RHINORRHOEA  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
NASAL CONGESTION  1  0/6 (0.00%)  0/6 (0.00%)  2/22 (9.09%)  0/26 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders           
RASH  1  2/6 (33.33%)  3/6 (50.00%)  2/22 (9.09%)  0/26 (0.00%)  0/11 (0.00%) 
NIGHT SWEATS  1  0/6 (0.00%)  2/6 (33.33%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
PRURITUS  1  1/6 (16.67%)  1/6 (16.67%)  2/22 (9.09%)  0/26 (0.00%)  0/11 (0.00%) 
DRY SKIN  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
EXFOLIATIVE RASH  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
HYPERHIDROSIS  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
SKIN INDURATION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
Vascular disorders           
DEEP VEIN THROMBOSIS  1  0/6 (0.00%)  1/6 (16.67%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
HYPOTENSION  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
PHLEBITIS SUPERFICIAL  1  1/6 (16.67%)  0/6 (0.00%)  0/22 (0.00%)  0/26 (0.00%)  0/11 (0.00%) 
HYPERTENSION  1  0/6 (0.00%)  0/6 (0.00%)  1/22 (4.55%)  1/26 (3.85%)  1/11 (9.09%) 
PHLEBITIS  1  0/6 (0.00%)  0/6 (0.00%)  0/22 (0.00%)  2/26 (7.69%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
The Sponsor terminated the study on 5 May 2010, prior to the completion of the 36-month follow-up (FU) period, based on the primary analysis results. All patients were off-study or in survival FU (the treatment period was completed).
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00400764     History of Changes
Other Study ID Numbers: APO3585g
First Submitted: November 15, 2006
First Posted: November 17, 2006
Results First Submitted: September 1, 2011
Results First Posted: October 7, 2011
Last Update Posted: November 23, 2011