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VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01666444
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Interventions Drug: pegylated liposomal doxorubicin (PLD)
Drug: VTX-2337
Drug: Placebo
Enrollment 297
Recruitment Details Enrollment was initiated on 2012-Aug-13 and terminated on 2014-Apr-11. During this time, 297 patients were enrolled.
Pre-assignment Details Prior to enrollment and treatment assignment, a completed eligibility checklist was electronically checked for completeness and compliance with eligibility criteria. Prior to treatment assignment, patients were stratified by prior platinum free interval (<6 months or >6-12 months) and performance status (0 or 1). Treatments were double-blinded.
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Hide Arm/Group Description Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Period Title: Overall Study
Started 149 148
Completed 147 147
Not Completed 2 1
Reason Not Completed
Did not initiate treatment             2             1
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) Total
Hide Arm/Group Description Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2 Total of all reporting groups
Overall Number of Baseline Participants 149 148 297
Hide Baseline Analysis Population Description
All enrolled patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 149 participants 148 participants 297 participants
61.6
(29.7 to 91.1)
63.5
(39.6 to 84.8)
62.7
(29.7 to 91.1)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
<40 years
4
   2.7%
1
   0.7%
5
   1.7%
40-49 years
22
  14.8%
11
   7.4%
33
  11.1%
50-59 years
39
  26.2%
42
  28.4%
81
  27.3%
60-69 years
50
  33.6%
51
  34.5%
101
  34.0%
70-79 years
31
  20.8%
38
  25.7%
69
  23.2%
> 79 years
3
   2.0%
5
   3.4%
8
   2.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
Female
149
 100.0%
148
 100.0%
297
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
Hispanic or Latino
4
   2.7%
3
   2.0%
7
   2.4%
Not Hispanic or Latino
143
  96.0%
145
  98.0%
288
  97.0%
Unknown or Not Reported
2
   1.3%
0
   0.0%
2
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
American Indian or Alaska Native
1
   0.7%
1
   0.7%
2
   0.7%
Asian
3
   2.0%
3
   2.0%
6
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   2.7%
6
   4.1%
10
   3.4%
White
141
  94.6%
137
  92.6%
278
  93.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.7%
1
   0.3%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
0 = Fully active, no restrictions
104
  69.8%
105
  70.9%
209
  70.4%
1=Restricted activity;ambulatory;can do light work
45
  30.2%
43
  29.1%
88
  29.6%
[1]
Measure Description:

ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).

The scale ranges from 0 to 5:

0 = Fully active, no restrictions;

  1. = Restricted activity but ambulatory, able to carry out work of a light nature;
  2. = Ambulatory and capable of all self-care but unable to carry out work activities;
  3. = Limited self-care, confined to bed or chair more than 50% of waking hours;
  4. = Completely disabled, no self-care, confined to bed or chair;
  5. = Dead
Prior Platinum-Free Interval as per Case Report Forms  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
<= 6 months
79
  53.0%
72
  48.6%
151
  50.8%
> 6 months
70
  47.0%
76
  51.4%
146
  49.2%
Prior Chemotherapy Regimens  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
1
81
  54.4%
69
  46.6%
150
  50.5%
2
64
  43.0%
74
  50.0%
138
  46.5%
3
4
   2.7%
5
   3.4%
9
   3.0%
1.Primary Outcome
Title Overall Survival
Hide Description Comparison of duration of survival between the 2 treatment groups
Time Frame Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Hide Arm/Group Description:
Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Overall Number of Participants Analyzed 149 148
Median (Inter-Quartile Range)
Unit of Measure: days
574
(242 to 1141)
552
(240 to 869)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegylated Liposomal Doxorubicin (PLD) + Placebo, Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Comments The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.923
Comments P-value is for a one-sided hypothesis test.
Method Log Rank
Comments The logrank test is stratified for platinum-free interval (<= 6 months vs > 6 months), and performance status (0 vs 1).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.22
Confidence Interval (1-Sided) 92%
1.48
Estimation Comments Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Comparison of PFS between the 2 treatment groups
Time Frame Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Hide Arm/Group Description:
Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Overall Number of Participants Analyzed 149 148
Median (Inter-Quartile Range)
Unit of Measure: days
159
(87 to 351)
147
(85 to 267)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegylated Liposomal Doxorubicin (PLD) + Placebo, Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Comments The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.943
Comments P-value is for a one-sided hypothesis test.
Method Log Rank
Comments The logrank test is stratified for platinum-free interval (<= 6 months vs > 6 months), and performance status (0 vs 1).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.21
Confidence Interval (1-Sided) 98%
1.56
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Frequency and Severity of Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death
Time Frame Assessed during each cycle of therapy and within 30 days after the last cycle of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who initiated study treatment. There were 147 patients who initiated treatment on each arm.
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Hide Arm/Group Description:
Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo
Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
Overall Number of Participants Analyzed 147 147
Measure Type: Number
Unit of Measure: participants
Grade 1 8 3
Grade 2 40 44
Grade 3 83 90
Grade 4 10 3
Grade 5 6 7
Time Frame Adverse Event assessments began with initiation of any study treatment up until 30 days following the last cycle of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Hide Arm/Group Description Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2
All-Cause Mortality
Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Affected / at Risk (%) Affected / at Risk (%)
Total   30/147 (20.41%)   36/147 (24.49%) 
Blood and lymphatic system disorders     
Anemia * 1  3/147 (2.04%)  2/147 (1.36%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/147 (0.68%)  1/147 (0.68%) 
Gastrointestinal disorders     
Constipation * 1  0/147 (0.00%)  2/147 (1.36%) 
Diarrhea * 1  1/147 (0.68%)  4/147 (2.72%) 
Vomiting * 1  5/147 (3.40%)  7/147 (4.76%) 
Upper Gastrointestinal Hemorrhage * 1  0/147 (0.00%)  1/147 (0.68%) 
Bloating * 1  0/147 (0.00%)  1/147 (0.68%) 
Small Intestinal Obstruction * 1  3/147 (2.04%)  0/147 (0.00%) 
Abdominal Pain * 1  3/147 (2.04%)  6/147 (4.08%) 
Mucositis Oral * 1  1/147 (0.68%)  0/147 (0.00%) 
Gastrointestinal Disorders - Other * 1  1/147 (0.68%)  1/147 (0.68%) 
Ileus * 1  0/147 (0.00%)  1/147 (0.68%) 
Abdominal Distension * 1  1/147 (0.68%)  2/147 (1.36%) 
Nausea * 1  8/147 (5.44%)  9/147 (6.12%) 
Esophageal Ulcer * 1  0/147 (0.00%)  1/147 (0.68%) 
Esophagitis * 1  1/147 (0.68%)  0/147 (0.00%) 
Ascites * 1  2/147 (1.36%)  1/147 (0.68%) 
General disorders     
Pain * 1  0/147 (0.00%)  2/147 (1.36%) 
Malaise * 1  1/147 (0.68%)  1/147 (0.68%) 
Injection Site Reaction * 1  0/147 (0.00%)  1/147 (0.68%) 
Non-Cardiac Chest Pain * 1  1/147 (0.68%)  0/147 (0.00%) 
Edema Limbs * 1  0/147 (0.00%)  1/147 (0.68%) 
Fatigue * 1  2/147 (1.36%)  4/147 (2.72%) 
Death Nos * 1  0/147 (0.00%)  1/147 (0.68%) 
Fever * 1  1/147 (0.68%)  3/147 (2.04%) 
Chills * 1  0/147 (0.00%)  1/147 (0.68%) 
Infections and infestations     
Sinusitis * 1  1/147 (0.68%)  0/147 (0.00%) 
Sepsis * 1  5/147 (3.40%)  1/147 (0.68%) 
Lung Infection * 1  0/147 (0.00%)  1/147 (0.68%) 
Cecal Infection * 1  0/147 (0.00%)  1/147 (0.68%) 
Urinary Tract Infection * 1  2/147 (1.36%)  2/147 (1.36%) 
Enterocolitis Infectious * 1  1/147 (0.68%)  0/147 (0.00%) 
Biliary Tract Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Injury, poisoning and procedural complications     
Spinal Fracture * 1  1/147 (0.68%)  0/147 (0.00%) 
Investigations     
Lymphocyte Count Decreased * 1  1/147 (0.68%)  0/147 (0.00%) 
Inr Increased * 1  0/147 (0.00%)  1/147 (0.68%) 
Creatinine Increased * 1  4/147 (2.72%)  0/147 (0.00%) 
Neutrophil Count Decreased * 1  1/147 (0.68%)  2/147 (1.36%) 
Blood Bilirubin Increased * 1  0/147 (0.00%)  1/147 (0.68%) 
White Blood Cell Decreased * 1  0/147 (0.00%)  1/147 (0.68%) 
Aspartate Aminotransferase Increased * 1  0/147 (0.00%)  1/147 (0.68%) 
Alkaline Phosphatase Increased * 1  0/147 (0.00%)  1/147 (0.68%) 
Alanine Aminotransferase Increased * 1  0/147 (0.00%)  1/147 (0.68%) 
Metabolism and nutrition disorders     
Hyponatremia * 1  1/147 (0.68%)  1/147 (0.68%) 
Hypomagnesemia * 1  1/147 (0.68%)  0/147 (0.00%) 
Hypokalemia * 1  1/147 (0.68%)  0/147 (0.00%) 
Hypocalcemia * 1  0/147 (0.00%)  1/147 (0.68%) 
Hypoalbuminemia * 1  0/147 (0.00%)  1/147 (0.68%) 
Hyperglycemia * 1  1/147 (0.68%)  0/147 (0.00%) 
Dehydration * 1  1/147 (0.68%)  2/147 (1.36%) 
Anorexia * 1  0/147 (0.00%)  3/147 (2.04%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  1/147 (0.68%)  1/147 (0.68%) 
Generalized Muscle Weakness * 1  0/147 (0.00%)  2/147 (1.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  0/147 (0.00%)  1/147 (0.68%) 
Nervous system disorders     
Stroke * 1  0/147 (0.00%)  1/147 (0.68%) 
Dysarthria * 1  0/147 (0.00%)  1/147 (0.68%) 
Cognitive Disturbance * 1  0/147 (0.00%)  1/147 (0.68%) 
Psychiatric disorders     
Confusion * 1  0/147 (0.00%)  1/147 (0.68%) 
Renal and urinary disorders     
Urinary Tract Obstruction * 1  1/147 (0.68%)  1/147 (0.68%) 
Acute Kidney Injury * 1  0/147 (0.00%)  2/147 (1.36%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  1/147 (0.68%)  0/147 (0.00%) 
Respiratory Failure * 1  1/147 (0.68%)  1/147 (0.68%) 
Pleural Effusion * 1  3/147 (2.04%)  3/147 (2.04%) 
Hypoxia * 1  1/147 (0.68%)  0/147 (0.00%) 
Dyspnea * 1  0/147 (0.00%)  3/147 (2.04%) 
Aspiration * 1  0/147 (0.00%)  1/147 (0.68%) 
Vascular disorders     
Thromboembolic Event * 1  1/147 (0.68%)  0/147 (0.00%) 
Hypotension * 1  0/147 (0.00%)  1/147 (0.68%) 
Hypertension * 1  1/147 (0.68%)  0/147 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pegylated Liposomal Doxorubicin (PLD) + Placebo Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX)
Affected / at Risk (%) Affected / at Risk (%)
Total   147/147 (100.00%)   147/147 (100.00%) 
Blood and lymphatic system disorders     
Anemia * 1  103/147 (70.07%)  105/147 (71.43%) 
Febrile Neutropenia * 1  0/147 (0.00%)  1/147 (0.68%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/147 (0.68%)  2/147 (1.36%) 
Ventricular Tachycardia * 1  1/147 (0.68%)  0/147 (0.00%) 
Sinus Bradycardia * 1  1/147 (0.68%)  2/147 (1.36%) 
Palpitations * 1  8/147 (5.44%)  6/147 (4.08%) 
Heart Failure * 1  0/147 (0.00%)  1/147 (0.68%) 
Atrial Flutter * 1  0/147 (0.00%)  1/147 (0.68%) 
Cardiac Disorders - Other * 1  1/147 (0.68%)  1/147 (0.68%) 
Pericardial Effusion * 1  0/147 (0.00%)  1/147 (0.68%) 
Sinus Tachycardia * 1  11/147 (7.48%)  6/147 (4.08%) 
Chest Pain - Cardiac * 1  1/147 (0.68%)  1/147 (0.68%) 
Ear and labyrinth disorders     
Middle Ear Inflammation * 1  1/147 (0.68%)  0/147 (0.00%) 
Ear And Labyrinth Disorders - Other * 1  0/147 (0.00%)  1/147 (0.68%) 
Vertigo * 1  1/147 (0.68%)  1/147 (0.68%) 
Tinnitus * 1  4/147 (2.72%)  5/147 (3.40%) 
Hearing Impaired * 1  0/147 (0.00%)  4/147 (2.72%) 
Ear Pain * 1  3/147 (2.04%)  1/147 (0.68%) 
External Ear Inflammation * 1  1/147 (0.68%)  0/147 (0.00%) 
Endocrine disorders     
Hyperthyroidism * 1  0/147 (0.00%)  1/147 (0.68%) 
Eye disorders     
Eye Disorders - Other * 1  3/147 (2.04%)  1/147 (0.68%) 
Watering Eyes * 1  2/147 (1.36%)  2/147 (1.36%) 
Flashing Lights * 1  1/147 (0.68%)  2/147 (1.36%) 
Eye Pain * 1  0/147 (0.00%)  3/147 (2.04%) 
Cataract * 1  4/147 (2.72%)  0/147 (0.00%) 
Conjunctivitis * 1  2/147 (1.36%)  1/147 (0.68%) 
Blurred Vision * 1  6/147 (4.08%)  5/147 (3.40%) 
Dry Eye * 1  3/147 (2.04%)  2/147 (1.36%) 
Floaters * 1  1/147 (0.68%)  2/147 (1.36%) 
Gastrointestinal disorders     
Enterocolitis * 1  1/147 (0.68%)  0/147 (0.00%) 
Dysphagia * 1  17/147 (11.56%)  12/147 (8.16%) 
Dyspepsia * 1  13/147 (8.84%)  22/147 (14.97%) 
Duodenal Obstruction * 1  2/147 (1.36%)  0/147 (0.00%) 
Dry Mouth * 1  10/147 (6.80%)  7/147 (4.76%) 
Colonic Obstruction * 1  4/147 (2.72%)  2/147 (1.36%) 
Colitis * 1  1/147 (0.68%)  0/147 (0.00%) 
Constipation * 1  75/147 (51.02%)  79/147 (53.74%) 
Diarrhea * 1  52/147 (35.37%)  45/147 (30.61%) 
Cheilitis * 1  1/147 (0.68%)  0/147 (0.00%) 
Vomiting * 1  48/147 (32.65%)  70/147 (47.62%) 
Upper Gastrointestinal Hemorrhage * 1  1/147 (0.68%)  0/147 (0.00%) 
Bloating * 1  26/147 (17.69%)  24/147 (16.33%) 
Small Intestinal Perforation * 1  1/147 (0.68%)  0/147 (0.00%) 
Stomach Pain * 1  7/147 (4.76%)  2/147 (1.36%) 
Small Intestinal Obstruction * 1  13/147 (8.84%)  12/147 (8.16%) 
Anal Hemorrhage * 1  1/147 (0.68%)  1/147 (0.68%) 
Anal Mucositis * 1  0/147 (0.00%)  1/147 (0.68%) 
Abdominal Pain * 1  54/147 (36.73%)  61/147 (41.50%) 
Periodontal Disease * 1  1/147 (0.68%)  0/147 (0.00%) 
Rectal Hemorrhage * 1  1/147 (0.68%)  3/147 (2.04%) 
Obstruction Gastric * 1  1/147 (0.68%)  0/147 (0.00%) 
Small Intestinal Mucositis * 1  0/147 (0.00%)  2/147 (1.36%) 
Mucositis Oral * 1  57/147 (38.78%)  56/147 (38.10%) 
Lower Gastrointestinal Hemorrhage * 1  1/147 (0.68%)  0/147 (0.00%) 
Gastrointestinal Disorders - Other * 1  3/147 (2.04%)  5/147 (3.40%) 
Anal Pain * 1  0/147 (0.00%)  1/147 (0.68%) 
Oral Hemorrhage * 1  1/147 (0.68%)  1/147 (0.68%) 
Ileus * 1  3/147 (2.04%)  5/147 (3.40%) 
Ileal Obstruction * 1  1/147 (0.68%)  1/147 (0.68%) 
Gastrointestinal Pain * 1  2/147 (1.36%)  1/147 (0.68%) 
Gastric Hemorrhage * 1  1/147 (0.68%)  0/147 (0.00%) 
Oral Pain * 1  10/147 (6.80%)  10/147 (6.80%) 
Abdominal Distension * 1  15/147 (10.20%)  15/147 (10.20%) 
Nausea * 1  93/147 (63.27%)  97/147 (65.99%) 
Gastroparesis * 1  2/147 (1.36%)  1/147 (0.68%) 
Gastric Ulcer * 1  1/147 (0.68%)  0/147 (0.00%) 
Gastroesophageal Reflux Disease * 1  12/147 (8.16%)  15/147 (10.20%) 
Rectal Pain * 1  1/147 (0.68%)  1/147 (0.68%) 
Lip Pain * 1  0/147 (0.00%)  1/147 (0.68%) 
Esophageal Ulcer * 1  0/147 (0.00%)  1/147 (0.68%) 
Esophagitis * 1  7/147 (4.76%)  2/147 (1.36%) 
Fecal Incontinence * 1  0/147 (0.00%)  1/147 (0.68%) 
Hemorrhoidal Hemorrhage * 1  0/147 (0.00%)  1/147 (0.68%) 
Hemorrhoids * 1  0/147 (0.00%)  3/147 (2.04%) 
Ascites * 1  15/147 (10.20%)  8/147 (5.44%) 
Toothache * 1  3/147 (2.04%)  3/147 (2.04%) 
Esophageal Pain * 1  1/147 (0.68%)  5/147 (3.40%) 
Dental Caries * 1  3/147 (2.04%)  0/147 (0.00%) 
Flatulence * 1  6/147 (4.08%)  6/147 (4.08%) 
Gastritis * 1  2/147 (1.36%)  2/147 (1.36%) 
General disorders     
General Disorders And Administration Site Conditio * 1  3/147 (2.04%)  7/147 (4.76%) 
Pain * 1  23/147 (15.65%)  26/147 (17.69%) 
Malaise * 1  7/147 (4.76%)  6/147 (4.08%) 
Localized Edema * 1  2/147 (1.36%)  1/147 (0.68%) 
Irritability * 1  0/147 (0.00%)  1/147 (0.68%) 
Injection Site Reaction * 1  13/147 (8.84%)  107/147 (72.79%) 
Infusion Site Extravasation * 1  2/147 (1.36%)  0/147 (0.00%) 
Flu Like Symptoms * 1  8/147 (5.44%)  45/147 (30.61%) 
Edema Trunk * 1  2/147 (1.36%)  1/147 (0.68%) 
Non-Cardiac Chest Pain * 1  6/147 (4.08%)  3/147 (2.04%) 
Edema Limbs * 1  19/147 (12.93%)  37/147 (25.17%) 
Facial Pain * 1  2/147 (1.36%)  1/147 (0.68%) 
Edema Face * 1  0/147 (0.00%)  1/147 (0.68%) 
Fatigue * 1  109/147 (74.15%)  127/147 (86.39%) 
Fever * 1  19/147 (12.93%)  70/147 (47.62%) 
Gait Disturbance * 1  2/147 (1.36%)  2/147 (1.36%) 
Chills * 1  25/147 (17.01%)  92/147 (62.59%) 
Infusion Related Reaction * 1  1/147 (0.68%)  5/147 (3.40%) 
Hepatobiliary disorders     
Hepatobiliary Disorders - Other * 1  0/147 (0.00%)  1/147 (0.68%) 
Cholecystitis * 1  1/147 (0.68%)  1/147 (0.68%) 
Immune system disorders     
Anaphylaxis * 1  1/147 (0.68%)  0/147 (0.00%) 
Allergic Reaction * 1  4/147 (2.72%)  4/147 (2.72%) 
Cytokine Release Syndrome * 1  2/147 (1.36%)  24/147 (16.33%) 
Immune System Disorders - Other * 1  1/147 (0.68%)  1/147 (0.68%) 
Infections and infestations     
Infections And Infestations - Other * 1  4/147 (2.72%)  2/147 (1.36%) 
Wound Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Upper Respiratory Infection * 1  3/147 (2.04%)  4/147 (2.72%) 
Tooth Infection * 1  1/147 (0.68%)  1/147 (0.68%) 
Stoma Site Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Vulval Infection * 1  2/147 (1.36%)  0/147 (0.00%) 
Soft Tissue Infection * 1  1/147 (0.68%)  1/147 (0.68%) 
Skin Infection * 1  6/147 (4.08%)  16/147 (10.88%) 
Sinusitis * 1  6/147 (4.08%)  4/147 (2.72%) 
Sepsis * 1  1/147 (0.68%)  0/147 (0.00%) 
Salivary Gland Infection * 1  0/147 (0.00%)  1/147 (0.68%) 
Rash Pustular * 1  1/147 (0.68%)  1/147 (0.68%) 
Peripheral Nerve Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Papulopustular Rash * 1  3/147 (2.04%)  2/147 (1.36%) 
Nail Infection * 1  1/147 (0.68%)  2/147 (1.36%) 
Mucosal Infection * 1  3/147 (2.04%)  2/147 (1.36%) 
Lymph Gland Infection * 1  0/147 (0.00%)  1/147 (0.68%) 
Lung Infection * 1  2/147 (1.36%)  3/147 (2.04%) 
Eye Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Device Related Infection * 1  1/147 (0.68%)  1/147 (0.68%) 
Gum Infection * 1  0/147 (0.00%)  2/147 (1.36%) 
Vaginal Infection * 1  4/147 (2.72%)  2/147 (1.36%) 
Urinary Tract Infection * 1  12/147 (8.16%)  12/147 (8.16%) 
Catheter Related Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Joint Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Bronchial Infection * 1  3/147 (2.04%)  0/147 (0.00%) 
Bone Infection * 1  1/147 (0.68%)  0/147 (0.00%) 
Bladder Infection * 1  3/147 (2.04%)  1/147 (0.68%) 
Lip Infection * 1  0/147 (0.00%)  3/147 (2.04%) 
Injury, poisoning and procedural complications     
Wound Dehiscence * 1  1/147 (0.68%)  0/147 (0.00%) 
Vascular Access Complication * 1  2/147 (1.36%)  0/147 (0.00%) 
Vaginal Anastomotic Leak * 1  0/147 (0.00%)  1/147 (0.68%) 
Urostomy Obstruction * 1  1/147 (0.68%)  0/147 (0.00%) 
Spinal Fracture * 1  2/147 (1.36%)  0/147 (0.00%) 
Radiation Recall Reaction (Dermatologic) * 1  0/147 (0.00%)  1/147 (0.68%) 
Fracture * 1  3/147 (2.04%)  0/147 (0.00%) 
Fall * 1  6/147 (4.08%)  7/147 (4.76%) 
Wound Complication * 1  0/147 (0.00%)  1/147 (0.68%) 
Burn * 1  1/147 (0.68%)  1/147 (0.68%) 
Bruising * 1  6/147 (4.08%)  8/147 (5.44%) 
Ankle Fracture * 1  2/147 (1.36%)  0/147 (0.00%) 
Investigations     
Investigations - Other * 1  2/147 (1.36%)  4/147 (2.72%) 
Weight Loss * 1  19/147 (12.93%)  25/147 (17.01%) 
Weight Gain * 1  5/147 (3.40%)  4/147 (2.72%) 
Platelet Count Decreased * 1  30/147 (20.41%)  18/147 (12.24%) 
Lymphocyte Count Decreased * 1  10/147 (6.80%)  15/147 (10.20%) 
Inr Increased * 1  5/147 (3.40%)  3/147 (2.04%) 
Hemoglobin Increased * 1  1/147 (0.68%)  0/147 (0.00%) 
Ggt Increased * 1  2/147 (1.36%)  2/147 (1.36%) 
Electrocardiogram Qt Corrected Interval Prolonged * 1  1/147 (0.68%)  0/147 (0.00%) 
Ejection Fraction Decreased * 1  1/147 (0.68%)  3/147 (2.04%) 
Creatinine Increased * 1  9/147 (6.12%)  11/147 (7.48%) 
Cholesterol High * 1  1/147 (0.68%)  1/147 (0.68%) 
Neutrophil Count Decreased * 1  60/147 (40.82%)  54/147 (36.73%) 
Urine Output Decreased * 1  1/147 (0.68%)  0/147 (0.00%) 
Cd4 Lymphocytes Decreased * 1  1/147 (0.68%)  2/147 (1.36%) 
Blood Bilirubin Increased * 1  1/147 (0.68%)  0/147 (0.00%) 
White Blood Cell Decreased * 1  83/147 (56.46%)  74/147 (50.34%) 
Aspartate Aminotransferase Increased * 1  14/147 (9.52%)  17/147 (11.56%) 
Alkaline Phosphatase Increased * 1  18/147 (12.24%)  18/147 (12.24%) 
Alanine Aminotransferase Increased * 1  12/147 (8.16%)  9/147 (6.12%) 
Activated Partial Thromboplastin Time Prolonged * 1  1/147 (0.68%)  1/147 (0.68%) 
Metabolism and nutrition disorders     
Metabolism And Nutrition Disorders - Other * 1  3/147 (2.04%)  2/147 (1.36%) 
Hypophosphatemia * 1  10/147 (6.80%)  6/147 (4.08%) 
Hyponatremia * 1  18/147 (12.24%)  21/147 (14.29%) 
Hypomagnesemia * 1  28/147 (19.05%)  24/147 (16.33%) 
Hypokalemia * 1  28/147 (19.05%)  12/147 (8.16%) 
Hypoglycemia * 1  7/147 (4.76%)  2/147 (1.36%) 
Hypocalcemia * 1  14/147 (9.52%)  15/147 (10.20%) 
Hypoalbuminemia * 1  27/147 (18.37%)  23/147 (15.65%) 
Hypertriglyceridemia * 1  1/147 (0.68%)  2/147 (1.36%) 
Hypernatremia * 1  5/147 (3.40%)  2/147 (1.36%) 
Hypermagnesemia * 1  1/147 (0.68%)  2/147 (1.36%) 
Hyperkalemia * 1  8/147 (5.44%)  4/147 (2.72%) 
Hyperglycemia * 1  28/147 (19.05%)  19/147 (12.93%) 
Hypercalcemia * 1  3/147 (2.04%)  3/147 (2.04%) 
Glucose Intolerance * 1  1/147 (0.68%)  0/147 (0.00%) 
Dehydration * 1  9/147 (6.12%)  11/147 (7.48%) 
Anorexia * 1  46/147 (31.29%)  48/147 (32.65%) 
Alkalosis * 1  0/147 (0.00%)  1/147 (0.68%) 
Musculoskeletal and connective tissue disorders     
Pain In Extremity * 1  15/147 (10.20%)  23/147 (15.65%) 
Osteoporosis * 1  2/147 (1.36%)  0/147 (0.00%) 
Neck Pain * 1  0/147 (0.00%)  5/147 (3.40%) 
Myalgia * 1  24/147 (16.33%)  20/147 (13.61%) 
Muscle Weakness Upper Limb * 1  1/147 (0.68%)  1/147 (0.68%) 
Muscle Weakness Lower Limb * 1  2/147 (1.36%)  3/147 (2.04%) 
Muscle Weakness Left-Sided * 1  0/147 (0.00%)  1/147 (0.68%) 
Joint Range Of Motion Decreased * 1  1/147 (0.68%)  0/147 (0.00%) 
Joint Effusion * 1  0/147 (0.00%)  1/147 (0.68%) 
Generalized Muscle Weakness * 1  12/147 (8.16%)  16/147 (10.88%) 
Flank Pain * 1  3/147 (2.04%)  3/147 (2.04%) 
Chest Wall Pain * 1  1/147 (0.68%)  2/147 (1.36%) 
Buttock Pain * 1  1/147 (0.68%)  2/147 (1.36%) 
Bone Pain * 1  8/147 (5.44%)  6/147 (4.08%) 
Back Pain * 1  26/147 (17.69%)  30/147 (20.41%) 
Avascular Necrosis * 1  0/147 (0.00%)  1/147 (0.68%) 
Arthritis * 1  3/147 (2.04%)  4/147 (2.72%) 
Arthralgia * 1  23/147 (15.65%)  17/147 (11.56%) 
Abdominal Soft Tissue Necrosis * 1  0/147 (0.00%)  1/147 (0.68%) 
Musculoskeletal And Connective Tissue Disorder - * 1  4/147 (2.72%)  2/147 (1.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms Benign, Malignant And Unspecified (Incl * 1  4/147 (2.72%)  0/147 (0.00%) 
Tumor Pain * 1  0/147 (0.00%)  1/147 (0.68%) 
Nervous system disorders     
Nervous System Disorders - Other * 1  2/147 (1.36%)  0/147 (0.00%) 
Tremor * 1  3/147 (2.04%)  3/147 (2.04%) 
Transient Ischemic Attacks * 1  0/147 (0.00%)  1/147 (0.68%) 
Somnolence * 1  1/147 (0.68%)  0/147 (0.00%) 
Seizure * 1  0/147 (0.00%)  1/147 (0.68%) 
Presyncope * 1  0/147 (0.00%)  2/147 (1.36%) 
Peripheral Sensory Neuropathy * 1  47/147 (31.97%)  45/147 (30.61%) 
Peripheral Motor Neuropathy * 1  6/147 (4.08%)  5/147 (3.40%) 
Paresthesia * 1  5/147 (3.40%)  7/147 (4.76%) 
Neuralgia * 1  2/147 (1.36%)  0/147 (0.00%) 
Memory Impairment * 1  3/147 (2.04%)  2/147 (1.36%) 
Lethargy * 1  0/147 (0.00%)  1/147 (0.68%) 
Hypersomnia * 1  0/147 (0.00%)  1/147 (0.68%) 
Headache * 1  34/147 (23.13%)  27/147 (18.37%) 
Facial Nerve Disorder * 1  0/147 (0.00%)  1/147 (0.68%) 
Dysphasia * 1  0/147 (0.00%)  1/147 (0.68%) 
Dysgeusia * 1  13/147 (8.84%)  7/147 (4.76%) 
Dysarthria * 1  0/147 (0.00%)  1/147 (0.68%) 
Syncope * 1  1/147 (0.68%)  1/147 (0.68%) 
Dizziness * 1  14/147 (9.52%)  24/147 (16.33%) 
Depressed Level Of Consciousness * 1  0/147 (0.00%)  1/147 (0.68%) 
Concentration Impairment * 1  0/147 (0.00%)  1/147 (0.68%) 
Cognitive Disturbance * 1  1/147 (0.68%)  3/147 (2.04%) 
Ataxia * 1  1/147 (0.68%)  1/147 (0.68%) 
Akathisia * 1  0/147 (0.00%)  1/147 (0.68%) 
Psychiatric disorders     
Psychiatric Disorders - Other * 1  0/147 (0.00%)  1/147 (0.68%) 
Suicidal Ideation * 1  0/147 (0.00%)  2/147 (1.36%) 
Psychosis * 1  0/147 (0.00%)  1/147 (0.68%) 
Insomnia * 1  16/147 (10.88%)  27/147 (18.37%) 
Hallucinations * 1  0/147 (0.00%)  1/147 (0.68%) 
Depression * 1  24/147 (16.33%)  24/147 (16.33%) 
Confusion * 1  4/147 (2.72%)  6/147 (4.08%) 
Anxiety * 1  24/147 (16.33%)  32/147 (21.77%) 
Agitation * 1  1/147 (0.68%)  6/147 (4.08%) 
Renal and urinary disorders     
Renal And Urinary Disorders - Other * 1  2/147 (1.36%)  6/147 (4.08%) 
Urine Discoloration * 1  1/147 (0.68%)  0/147 (0.00%) 
Urinary Urgency * 1  2/147 (1.36%)  5/147 (3.40%) 
Urinary Tract Obstruction * 1  5/147 (3.40%)  0/147 (0.00%) 
Urinary Retention * 1  1/147 (0.68%)  0/147 (0.00%) 
Urinary Incontinence * 1  5/147 (3.40%)  11/147 (7.48%) 
Urinary Tract Pain * 1  4/147 (2.72%)  1/147 (0.68%) 
Urinary Frequency * 1  7/147 (4.76%)  13/147 (8.84%) 
Proteinuria * 1  3/147 (2.04%)  1/147 (0.68%) 
Hemoglobinuria * 1  2/147 (1.36%)  0/147 (0.00%) 
Hematuria * 1  5/147 (3.40%)  1/147 (0.68%) 
Chronic Kidney Disease * 1  3/147 (2.04%)  3/147 (2.04%) 
Acute Kidney Injury * 1  1/147 (0.68%)  2/147 (1.36%) 
Reproductive system and breast disorders     
Reproductive System And Breast Disorders - Other * 1  0/147 (0.00%)  1/147 (0.68%) 
Vaginal Pain * 1  1/147 (0.68%)  0/147 (0.00%) 
Vaginal Hemorrhage * 1  6/147 (4.08%)  5/147 (3.40%) 
Vaginal Dryness * 1  3/147 (2.04%)  1/147 (0.68%) 
Pelvic Pain * 1  4/147 (2.72%)  5/147 (3.40%) 
Vaginal Discharge * 1  8/147 (5.44%)  5/147 (3.40%) 
Vaginal Inflammation * 1  1/147 (0.68%)  1/147 (0.68%) 
Breast Pain * 1  1/147 (0.68%)  0/147 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic And Mediastinal Disorders - * 1  0/147 (0.00%)  1/147 (0.68%) 
Sore Throat * 1  6/147 (4.08%)  6/147 (4.08%) 
Sneezing * 1  1/147 (0.68%)  1/147 (0.68%) 
Sinus Disorder * 1  0/147 (0.00%)  2/147 (1.36%) 
Postnasal Drip * 1  5/147 (3.40%)  4/147 (2.72%) 
Pneumothorax * 1  0/147 (0.00%)  1/147 (0.68%) 
Pneumonitis * 1  1/147 (0.68%)  1/147 (0.68%) 
Pleural Effusion * 1  7/147 (4.76%)  9/147 (6.12%) 
Pharyngolaryngeal Pain * 1  1/147 (0.68%)  0/147 (0.00%) 
Pharyngeal Mucositis * 1  1/147 (0.68%)  0/147 (0.00%) 
Nasal Congestion * 1  10/147 (6.80%)  12/147 (8.16%) 
Pleuritic Pain * 1  0/147 (0.00%)  2/147 (1.36%) 
Productive Cough * 1  3/147 (2.04%)  1/147 (0.68%) 
Hypoxia * 1  3/147 (2.04%)  2/147 (1.36%) 
Hoarseness * 1  0/147 (0.00%)  2/147 (1.36%) 
Sleep Apnea * 1  1/147 (0.68%)  0/147 (0.00%) 
Hiccups * 1  1/147 (0.68%)  2/147 (1.36%) 
Epistaxis * 1  5/147 (3.40%)  4/147 (2.72%) 
Dyspnea * 1  40/147 (27.21%)  39/147 (26.53%) 
Cough * 1  29/147 (19.73%)  36/147 (24.49%) 
Wheezing * 1  3/147 (2.04%)  1/147 (0.68%) 
Atelectasis * 1  3/147 (2.04%)  0/147 (0.00%) 
Aspiration * 1  0/147 (0.00%)  1/147 (0.68%) 
Allergic Rhinitis * 1  3/147 (2.04%)  5/147 (3.40%) 
Skin and subcutaneous tissue disorders     
Skin And Subcutaneous Tissue Disorders - Other * 1  8/147 (5.44%)  15/147 (10.20%) 
Urticaria * 1  2/147 (1.36%)  3/147 (2.04%) 
Stevens-Johnson Syndrome * 1  1/147 (0.68%)  0/147 (0.00%) 
Skin Ulceration * 1  4/147 (2.72%)  5/147 (3.40%) 
Skin Induration * 1  1/147 (0.68%)  7/147 (4.76%) 
Skin Hyperpigmentation * 1  20/147 (13.61%)  21/147 (14.29%) 
Scalp Pain * 1  0/147 (0.00%)  1/147 (0.68%) 
Rash Acneiform * 1  7/147 (4.76%)  9/147 (6.12%) 
Purpura * 1  2/147 (1.36%)  0/147 (0.00%) 
Pruritus * 1  24/147 (16.33%)  20/147 (13.61%) 
Photosensitivity * 1  2/147 (1.36%)  1/147 (0.68%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  55/147 (37.41%)  54/147 (36.73%) 
Pain Of Skin * 1  6/147 (4.08%)  4/147 (2.72%) 
Rash Maculo-Papular * 1  58/147 (39.46%)  53/147 (36.05%) 
Nail Ridging * 1  1/147 (0.68%)  2/147 (1.36%) 
Nail Loss * 1  2/147 (1.36%)  2/147 (1.36%) 
Nail Discoloration * 1  8/147 (5.44%)  2/147 (1.36%) 
Hyperhidrosis * 1  4/147 (2.72%)  3/147 (2.04%) 
Erythema Multiforme * 1  5/147 (3.40%)  8/147 (5.44%) 
Dry Skin * 1  21/147 (14.29%)  24/147 (16.33%) 
Bullous Dermatitis * 1  6/147 (4.08%)  2/147 (1.36%) 
Alopecia * 1  14/147 (9.52%)  20/147 (13.61%) 
Surgical and medical procedures     
Surgical And Medical Procedures - Other * 1  1/147 (0.68%)  3/147 (2.04%) 
Vascular disorders     
Vascular Disorders - Other * 1  1/147 (0.68%)  0/147 (0.00%) 
Thromboembolic Event * 1  7/147 (4.76%)  5/147 (3.40%) 
Superficial Thrombophlebitis * 1  1/147 (0.68%)  0/147 (0.00%) 
Lymphedema * 1  5/147 (3.40%)  4/147 (2.72%) 
Hypotension * 1  6/147 (4.08%)  11/147 (7.48%) 
Hypertension * 1  13/147 (8.84%)  18/147 (12.24%) 
Hot Flashes * 1  13/147 (8.84%)  7/147 (4.76%) 
Hematoma * 1  3/147 (2.04%)  4/147 (2.72%) 
Flushing * 1  1/147 (0.68%)  1/147 (0.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Kristi Manjarrez
Organization: Vice President, Clinical Affairs
Phone: 206-689-2256
EMail: kmanjarrez@ventirx.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01666444    
Other Study ID Numbers: GOG-3003
First Submitted: August 10, 2012
First Posted: August 16, 2012
Results First Submitted: March 5, 2017
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019