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An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)

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ClinicalTrials.gov Identifier: NCT00738699
Recruitment Status : Terminated (study did not meet pre-specified criteria for continuation following interim futility analysis)
First Posted : August 20, 2008
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Morphotek

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: MORAb-003 (farletuzumab)
Drug: 0.9% Saline
Drug: Paclitaxel
Enrollment 415

Recruitment Details  
Pre-assignment Details  
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion. An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Period Title: Overall Study
Started 275 140
Participants Not Treated 2 1
Participants Treated 273 139
Completed 0 0
Not Completed 275 140
Reason Not Completed
Withdrawal by Subject             5             0
Lost to Follow-up             1             0
Death             144             68
Discontinuation of study by Sponsor             123             72
Not specified             2             0
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel Total
Hide Arm/Group Description Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion. An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion. Total of all reporting groups
Overall Number of Baseline Participants 275 140 415
Hide Baseline Analysis Population Description
Intent-to-Treat population included, the primary population for the evaluation of efficacy, was defined as all participant who were randomly assigned to test article, analyzed by the treatment assigned.
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 140 participants 415 participants
60.9  (10.74) 61.2  (9.44) 61.0  (10.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 140 participants 415 participants
Female
275
 100.0%
140
 100.0%
415
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Time Frame Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description:
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed 275 140
Median (95% Confidence Interval)
Unit of Measure: Months
3.5
(3.3 to 3.9)
3.7
(3.3 to 5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MORAb-003 (Farletuzumab) Plus Paclitaxel, Placebo (Normal Saline) Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8360
Comments One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.88 to 1.46
Estimation Comments Stratified as described above.
2.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
Time Frame Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description:
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed 275 140
Median (95% Confidence Interval)
Unit of Measure: Months
11.3
(10.3 to 12.7)
13.1
(10.3 to 16.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MORAb-003 (Farletuzumab) Plus Paclitaxel, Placebo (Normal Saline) Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7568
Comments One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.83 to 1.48
Estimation Comments Stratified as described above
3.Secondary Outcome
Title Best Overall Response
Hide Description BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
Time Frame Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description:
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed 275 140
Measure Type: Number
Unit of Measure: Percentage of participants
Complete response (CR) 0.4 0
Partial response (PR) 7.3 15.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MORAb-003 (Farletuzumab) Plus Paclitaxel, Placebo (Normal Saline) Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0399
Comments Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -7.4
Confidence Interval (2-Sided) 95%
-14.1 to -0.7
Estimation Comments (FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.
4.Secondary Outcome
Title Time to Tumor Response (TTR)
Hide Description TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
Time Frame Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description:
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed 21 21
Median (95% Confidence Interval)
Unit of Measure: Months
2.0
(1.6 to 3.5)
1.7
(1.6 to 3.3)
5.Other Pre-specified Outcome
Title Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)
Hide Description Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
Time Frame Length of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description:
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Serologic Response Rate
Hide Description Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.
Time Frame Length of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description:
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Adverse Event Reporting Description Safety Analysis Set was defined as all randomized participants who received any dose of FAR or placebo, analyzed according to the test article received. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 was used to grade severity of AEs. Treatment-emergent adverse events were reported.
 
Arm/Group Title MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Hide Arm/Group Description Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion. An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
All-Cause Mortality
MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   127/279 (45.52%)   55/133 (41.35%) 
Blood and lymphatic system disorders     
Anaemia * 1  7/279 (2.51%)  7/133 (5.26%) 
Neutropenia  2  6/279 (2.15%)  1/133 (0.75%) 
Febrile Neutropenia  2  4/279 (1.43%)  1/133 (0.75%) 
Leukopenia  2  2/279 (0.72%)  0/133 (0.00%) 
Cardiac disorders     
Atrial Fibrillation  2  2/279 (0.72%)  1/133 (0.75%) 
Cardiac Failure Congestive  2  1/279 (0.36%)  0/133 (0.00%) 
Cardio-Respiratory Arrest  2  1/279 (0.36%)  0/133 (0.00%) 
Gastrointestinal disorders     
Small Intestinal Obstruction  2  18/279 (6.45%)  7/133 (5.26%) 
Intestinal Obstruction  2  10/279 (3.58%)  4/133 (3.01%) 
Vomiting  2  9/279 (3.23%)  5/133 (3.76%) 
Constipation  2  9/279 (3.23%)  2/133 (1.50%) 
Ascites  2  8/279 (2.87%)  2/133 (1.50%) 
Nausea  2  5/279 (1.79%)  3/133 (2.26%) 
Abdominal Pain  2  5/279 (1.79%)  1/133 (0.75%) 
Diarrhoea  2  2/279 (0.72%)  3/133 (2.26%) 
Colonic Obstruction  2  3/279 (1.08%)  0/133 (0.00%) 
Ileus  2  2/279 (0.72%)  1/133 (0.75%) 
Gastrointestinal Haemorrhage  2  2/279 (0.72%)  0/133 (0.00%) 
Gastrointestinal Obstruction  2  1/279 (0.36%)  1/133 (0.75%) 
Intestinal Perforation  2  2/279 (0.72%)  0/133 (0.00%) 
Large Intestinal Obstruction  2  1/279 (0.36%)  1/133 (0.75%) 
Large Intestine Perforation  2  1/279 (0.36%)  1/133 (0.75%) 
Abdominal adhesions  2  1/279 (0.36%)  0/133 (0.00%) 
Colonic Pseudo-obstruction  2  1/279 (0.36%)  0/133 (0.00%) 
Diverticulum  2  1/279 (0.36%)  0/133 (0.00%) 
Enterocutaneous Fistula  2  1/279 (0.36%)  0/133 (0.00%) 
Faecal Volume Decreased  2  1/279 (0.36%)  0/133 (0.00%) 
Faecal Volume Increased  2  1/279 (0.36%)  0/133 (0.00%) 
Gastric Ulcer  2  1/279 (0.36%)  0/133 (0.00%) 
Gastrointestinal Inflammation  2  1/279 (0.36%)  0/133 (0.00%) 
Gastrointestinal Perforation  2  1/279 (0.36%)  0/133 (0.00%) 
Oesophageal Obstruction  2  1/279 (0.36%)  0/133 (0.00%) 
Rectourethral Fistula  2  1/279 (0.36%)  0/133 (0.00%) 
Short-Bowel Syndrome  2  1/279 (0.36%)  0/133 (0.00%) 
General disorders     
Disease Progression  2  17/279 (6.09%)  7/133 (5.26%) 
Pyrexia  2  15/279 (5.38%)  2/133 (1.50%) 
Fatigue  2  3/279 (1.08%)  1/133 (0.75%) 
Asthenia  2  1/279 (0.36%)  1/133 (0.75%) 
Obstruction  2  1/279 (0.36%)  1/133 (0.75%) 
Pain  2  1/279 (0.36%)  1/133 (0.75%) 
Generalised Oedema * 1  1/279 (0.36%)  0/133 (0.00%) 
Hernia Obstructive  2  1/279 (0.36%)  0/133 (0.00%) 
Oedema Peripheral  2  1/279 (0.36%)  0/133 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute * 1  1/279 (0.36%)  1/133 (0.75%) 
Cholangitis  2  1/279 (0.36%)  0/133 (0.00%) 
Infections and infestations     
Cellulitis * 1  6/279 (2.15%)  2/133 (1.50%) 
Urinary Tract Infection  2  5/279 (1.79%)  3/133 (2.26%) 
Pneumonia  2  4/279 (1.43%)  2/133 (1.50%) 
Sepsis  2  3/279 (1.08%)  1/133 (0.75%) 
Catheter Site Infection  2  1/279 (0.36%)  1/133 (0.75%) 
Device Related Infection  2  1/279 (0.36%)  1/133 (0.75%) 
Infection  2  1/279 (0.36%)  1/133 (0.75%) 
Lobar Pneumonia  2  1/279 (0.36%)  1/133 (0.75%) 
Abdominal Infection  2  0/279 (0.00%)  1/133 (0.75%) 
Bacterial Pyelonephritis  2  1/279 (0.36%)  0/133 (0.00%) 
Candida Sepsis * 1  1/279 (0.36%)  0/133 (0.00%) 
Clostridium Difficle Colitis  2  1/279 (0.36%)  0/133 (0.00%) 
Escherichia Sepsis  2  0/279 (0.00%)  1/133 (0.75%) 
Herpes Zoster  2  1/279 (0.36%)  0/133 (0.00%) 
Incision Site Infection  2  0/279 (0.00%)  1/133 (0.75%) 
Infectious Peritonitis  2  0/279 (0.00%)  1/133 (0.75%) 
Klebsiella Bacteraemia  2  0/279 (0.00%)  1/133 (0.75%) 
Meningitis  2  0/279 (0.00%)  1/133 (0.75%) 
Parotitis  2  1/279 (0.36%)  0/133 (0.00%) 
Pelvic Infection  2  1/279 (0.36%)  0/133 (0.00%) 
Postoperative Wound Infection  2  1/279 (0.36%)  0/133 (0.00%) 
Pseudomonal Sepsis  2  1/279 (0.36%)  0/133 (0.00%) 
Respiratory Tract Infection * 1  1/279 (0.36%)  0/133 (0.00%) 
Retroperitoneal Abcess  2  1/279 (0.36%)  0/133 (0.00%) 
Urosepsis  2  1/279 (0.36%)  0/133 (0.00%) 
Pneumonia bacterial * 1  1/279 (0.36%)  0/133 (0.00%) 
Injury, poisoning and procedural complications     
Postoperative Ileus  2  0/279 (0.00%)  1/133 (0.75%) 
Tibia fracture  2  1/279 (0.36%)  0/133 (0.00%) 
Investigations     
Haemoglobin Decreased  2  0/279 (0.00%)  1/133 (0.75%) 
Weight decreased  2  1/279 (0.36%)  0/133 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  2  4/279 (1.43%)  0/133 (0.00%) 
Decreased Appetite  2  1/279 (0.36%)  0/133 (0.00%) 
Failure to thrive  2  1/279 (0.36%)  0/133 (0.00%) 
Hypocalcaemia  2  1/279 (0.36%)  0/133 (0.00%) 
Hypokalaemia  2  1/279 (0.36%)  0/133 (0.00%) 
Hypomagnesaemia * 1  1/279 (0.36%)  0/133 (0.00%) 
Hyponatraemia  2  1/279 (0.36%)  0/133 (0.00%) 
Hypophagia * 1  1/279 (0.36%)  0/133 (0.00%) 
Malnutrition  2  1/279 (0.36%)  0/133 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  2  2/279 (0.72%)  1/133 (0.75%) 
Fistula  2  1/279 (0.36%)  0/133 (0.00%) 
Muscle Necrosis  2  0/279 (0.00%)  1/133 (0.75%) 
Muscular Weakness  2  1/279 (0.36%)  0/133 (0.00%) 
Musculoskeletal Chest Pain  2  0/279 (0.00%)  1/133 (0.75%) 
Myalgia  2  1/279 (0.36%)  0/133 (0.00%) 
Pain in Extremity  2  1/279 (0.36%)  0/133 (0.00%) 
Systemic Lupus Erythematosus  2  0/279 (0.00%)  1/133 (0.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oncologic Complication * 1  3/279 (1.08%)  0/133 (0.00%) 
Metastases to Central Nervous System  2  0/279 (0.00%)  2/133 (1.50%) 
Colon Cancer  2  1/279 (0.36%)  0/133 (0.00%) 
Metastatic Neoplasm  2  1/279 (0.36%)  0/133 (0.00%) 
Tumour Associated Fever  2  1/279 (0.36%)  0/133 (0.00%) 
Nervous system disorders     
Syncope  2  2/279 (0.72%)  1/133 (0.75%) 
Brain Mass  2  1/279 (0.36%)  0/133 (0.00%) 
Convulsion  2  1/279 (0.36%)  0/133 (0.00%) 
Encephelopathy  2  0/279 (0.00%)  1/133 (0.75%) 
Lethargy  2  1/279 (0.36%)  0/133 (0.00%) 
Mononeuritis  2  0/279 (0.00%)  1/133 (0.75%) 
Neuropathy Peripheral  2  1/279 (0.36%)  0/133 (0.00%) 
Posterior Reversible Encephelopathy Syndrome  2  1/279 (0.36%)  0/133 (0.00%) 
Psychiatric disorders     
Depression * 1  2/279 (0.72%)  1/133 (0.75%) 
Anxiety  2  1/279 (0.36%)  0/133 (0.00%) 
Disorientation  2  1/279 (0.36%)  0/133 (0.00%) 
Mental Status Change  2  1/279 (0.36%)  0/133 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute  2  2/279 (0.72%)  2/133 (1.50%) 
Hydronephrosis  2  2/279 (0.72%)  1/133 (0.75%) 
Renal Failure  2  1/279 (0.36%)  2/133 (1.50%) 
Bladder Spasm  2  1/279 (0.36%)  0/133 (0.00%) 
Dysuria  2  1/279 (0.36%)  0/133 (0.00%) 
Renal Impairment  2  0/279 (0.00%)  1/133 (0.75%) 
Ureteric Obstruction  2  1/279 (0.36%)  0/133 (0.00%) 
Urinary Tract Obstruction  2  1/279 (0.36%)  0/133 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism * 1  10/279 (3.58%)  4/133 (3.01%) 
Dyspnoea  2  7/279 (2.51%)  4/133 (3.01%) 
Pleural Effusion  2  3/279 (1.08%)  2/133 (1.50%) 
Pneumonitis * 1  5/279 (1.79%)  0/133 (0.00%) 
Epistaxis  2  1/279 (0.36%)  0/133 (0.00%) 
Interstitial Lung Disease  2  1/279 (0.36%)  0/133 (0.00%) 
Respiratory Failure  2  1/279 (0.36%)  0/133 (0.00%) 
Tachypnoea  2  0/279 (0.00%)  1/133 (0.75%) 
Skin and subcutaneous tissue disorders     
Dermatits Exfoliative  2  0/279 (0.00%)  1/133 (0.75%) 
Palmar-Plantar Erythrodysaesthesia Syndrome  2  1/279 (0.36%)  0/133 (0.00%) 
Rash  2  1/279 (0.36%)  0/133 (0.00%) 
Skin Toxicity  2  1/279 (0.36%)  0/133 (0.00%) 
Vascular disorders     
Hypotension  2  2/279 (0.72%)  2/133 (1.50%) 
Thrombosis  2  3/279 (1.08%)  0/133 (0.00%) 
Deep Vein Thrombosis  2  1/279 (0.36%)  1/133 (0.75%) 
Subclavian Vein Thrombosis  2  1/279 (0.36%)  0/133 (0.00%) 
Superior Vena Cava Syndrome  2  0/279 (0.00%)  1/133 (0.75%) 
Venous Thrombosis Limb  2  1/279 (0.36%)  0/133 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 14.1
2
Term from vocabulary, Select
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MORAb-003 (Farletuzumab) Plus Paclitaxel Placebo (Normal Saline) Plus Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   278/279 (99.64%)   133/133 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  2  78/279 (27.96%)  37/133 (27.82%) 
Neutropenia  2  38/279 (13.62%)  18/133 (13.53%) 
Leukopenia  2  16/279 (5.73%)  9/133 (6.77%) 
Eye disorders     
Vision Blurred  2  14/279 (5.02%)  8/133 (6.02%) 
Gastrointestinal disorders     
Nausea * 1  132/279 (47.31%)  66/133 (49.62%) 
Diarrhoea  2  119/279 (42.65%)  53/133 (39.85%) 
Constipation  2  96/279 (34.41%)  53/133 (39.85%) 
Abdominal pain  2  88/279 (31.54%)  34/133 (25.56%) 
Vomiting  2  84/279 (30.11%)  37/133 (27.82%) 
Abdominal Distension  2  51/279 (18.28%)  21/133 (15.79%) 
Ascites  2  22/279 (7.89%)  11/133 (8.27%) 
Stomatitis  2  26/279 (9.32%)  7/133 (5.26%) 
Dyspepsia  2  22/279 (7.89%)  10/133 (7.52%) 
Abdominal Pain Upper  2  25/279 (8.96%)  6/133 (4.51%) 
Dry mouth  2  19/279 (6.81%)  8/133 (6.02%) 
Small intestinal Obstruction  2  19/279 (6.81%)  7/133 (5.26%) 
Flatulence  2  18/279 (6.45%)  5/133 (3.76%) 
Gastroresophageal Reflux Disease  2  10/279 (3.58%)  8/133 (6.02%) 
General disorders     
Fatigue  2  184/279 (65.95%)  82/133 (61.65%) 
Oedema Peripheral  2  60/279 (21.51%)  26/133 (19.55%) 
Pyrexia  2  43/279 (15.41%)  18/133 (13.53%) 
Asthenia  2  24/279 (8.60%)  12/133 (9.02%) 
Mucosal Inflammation  2  24/279 (8.60%)  11/133 (8.27%) 
Chills  2  18/279 (6.45%)  7/133 (5.26%) 
Disease Progression  2  17/279 (6.09%)  7/133 (5.26%) 
Pain  2  17/279 (6.09%)  7/133 (5.26%) 
Oedema  2  6/279 (2.15%)  7/133 (5.26%) 
Infections and infestations     
Urinary Tract Infection  2  47/279 (16.85%)  30/133 (22.56%) 
Upper Respiratory Tract Infection  2  24/279 (8.60%)  6/133 (4.51%) 
Nasopharyngitits  2  16/279 (5.73%)  4/133 (3.01%) 
Sinusitis  2  10/279 (3.58%)  9/133 (6.77%) 
Injury, poisoning and procedural complications     
Contusion  2  19/279 (6.81%)  1/133 (0.75%) 
Metabolism and nutrition disorders     
Decreased Appetite  2  67/279 (24.01%)  27/133 (20.30%) 
Hypomagnesaemia  2  31/279 (11.11%)  18/133 (13.53%) 
Hypokalaemia  2  28/279 (10.04%)  9/133 (6.77%) 
Dehydration  2  14/279 (5.02%)  5/133 (3.76%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  43/279 (15.41%)  22/133 (16.54%) 
Back Pain  2  36/279 (12.90%)  26/133 (19.55%) 
Myalgia  2  28/279 (10.04%)  17/133 (12.78%) 
Pain In Extremity  2  31/279 (11.11%)  12/133 (9.02%) 
Muscle Spasms  2  14/279 (5.02%)  12/133 (9.02%) 
Musculoskeletal Pain  2  15/279 (5.38%)  6/133 (4.51%) 
Musculoskeletal Chest Pain  2  14/279 (5.02%)  6/133 (4.51%) 
Nervous system disorders     
Neuropathy Peripheral * 1  75/279 (26.88%)  37/133 (27.82%) 
Headache  2  72/279 (25.81%)  28/133 (21.05%) 
Dizziness  2  42/279 (15.05%)  18/133 (13.53%) 
Peripheral Sensory Neuropathy  2  38/279 (13.62%)  15/133 (11.28%) 
Dysguesia  2  29/279 (10.39%)  22/133 (16.54%) 
Restless Legs Syndrome  2  14/279 (5.02%)  2/133 (1.50%) 
Hypoaesthesia  2  6/279 (2.15%)  7/133 (5.26%) 
Psychiatric disorders     
Insomnia  2  54/279 (19.35%)  23/133 (17.29%) 
Anxiety  2  25/279 (8.96%)  16/133 (12.03%) 
Depression  2  24/279 (8.60%)  8/133 (6.02%) 
Renal and urinary disorders     
Dysuria  2  9/279 (3.23%)  12/133 (9.02%) 
Pollakiuria  2  7/279 (2.51%)  9/133 (6.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  58/279 (20.79%)  27/133 (20.30%) 
Dyspnoea  2  56/279 (20.07%)  21/133 (15.79%) 
Epistaxis  2  50/279 (17.92%)  25/133 (18.80%) 
Dyspnoea Exertional  2  29/279 (10.39%)  6/133 (4.51%) 
Oropharyngeal Pain  2  16/279 (5.73%)  13/133 (9.77%) 
Nasal Congestion  2  9/279 (3.23%)  9/133 (6.77%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  143/279 (51.25%)  59/133 (44.36%) 
Rash  2  55/279 (19.71%)  19/133 (14.29%) 
Nail disorder  2  47/279 (16.85%)  19/133 (14.29%) 
Dry skin  2  18/279 (6.45%)  7/133 (5.26%) 
Erythema  2  18/279 (6.45%)  6/133 (4.51%) 
Pruritus  2  15/279 (5.38%)  8/133 (6.02%) 
Hyperhidrosis  2  13/279 (4.66%)  7/133 (5.26%) 
Nail discolouration  2  11/279 (3.94%)  7/133 (5.26%) 
Vascular disorders     
Flushing  2  28/279 (10.04%)  9/133 (6.77%) 
Hypotension  2  10/279 (3.58%)  7/133 (5.26%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDra 14.1
2
Term from vocabulary, Select
This study was prematurely terminated by the sponsor following results of the preplanned futility analysis showing the study was unlikely to meet its statistically-defined coprimary endpoints.
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.
 
Results Point of Contact
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
Phone: 1-888-422-4743
Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00738699     History of Changes
Other Study ID Numbers: MORAb003-003PR
First Submitted: August 18, 2008
First Posted: August 20, 2008
Results First Submitted: December 13, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017