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A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

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: NCT00379639
Recruitment Status : Completed
First Posted : September 22, 2006
Results First Posted : August 13, 2012
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Romidepsin
Drug: Gemcitabine
Enrollment 36
Recruitment Details  
Pre-assignment Details Patients were assigned to 1 of 2 dose schedules concurrently on an every-other-patient basis using a "3+3" dosing scheme: Patients in Schedule A received study treatment Days 1, 8, and 15 and those in Schedule B on Days 1 and 15 of every 28-day cycle. Patients were observed for 28 days before enrollment at the next dose level, based on toxicities.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Hide Arm/Group Description Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days. Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days. Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days. Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days. Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Period Title: Overall Study
Started 7 [1] 7 [1] 10 [1] 6 [1] 6 [1]
Efficacy Evaluable Population 6 [2] 7 [2] 7 [2] 4 [2] 3 [2]
Completed 6 Cycles of Therapy 4 2 1 0 0
Completed 4 [3] 2 [3] 1 [3] 0 [3] 0 [3]
Not Completed 3 5 9 6 6
Reason Not Completed
Disease Progression             3             3             3             4             4
Physician Decision             0             2             1             1             0
Symptomatic Deterioration             0             0             1             0             1
Adverse Event             0             0             1             0             1
Lost to Follow-up             0             0             0             1             0
Other             0             0             3             0             0
[1]
Represents the number of patients who received any amount of study drug.
[2]
Completed ≥2 consecutive treatment cycles, had ≥1 efficacy assessment & no major protocol violations
[3]
Represents patients who completed the study through Cycle 6
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8 Total
Hide Arm/Group Description Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days. Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days. Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days. Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days. Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days. Total of all reporting groups
Overall Number of Baseline Participants 7 7 10 6 6 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
58.9  (11.25) 53.4  (11.04) 62.6  (10.86) 57.3  (15.54) 57.0  (13.37) 58.3  (11.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
Female
5
  71.4%
5
  71.4%
4
  40.0%
6
 100.0%
5
  83.3%
25
  69.4%
Male
2
  28.6%
2
  28.6%
6
  60.0%
0
   0.0%
1
  16.7%
11
  30.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
7
 100.0%
10
 100.0%
6
 100.0%
6
 100.0%
36
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
White 6 6 10 6 6 34
Black 1 0 0 0 0 1
Pakistani 0 1 0 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
7 7 10 6 6 36
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
169.3  (9.52) 163.7  (8.13) 170.9  (10.33) 159.6  (4.09) 164.9  (8.71) 166.3  (9.21)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
79.8  (20.54) 77.6  (25.21) 73.1  (12.58) 69.0  (26.84) 61.7  (27.56) 72.7  (21.70)
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 7 participants 7 participants 10 participants 6 participants 6 participants 36 participants
1.9  (0.28) 1.8  (0.29) 1.8  (0.19) 1.7  (0.23) 1.7  (0.35) 1.8  (0.27)
1.Primary Outcome
Title Number of Participants With a Dose-limiting Toxicity (DLT)
Hide Description

Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:

Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1.

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population - all participants who received at least one dose of study drug.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Hide Arm/Group Description:
Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Overall Number of Participants Analyzed 7 7 10 6 6
Measure Type: Number
Unit of Measure: participants
3 1 0 2 0
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.

A serious AE is associated with events that pose a threat to a patient's life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes.

Time Frame From the date of first dose to 30 days after last dose (up to 236 days).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Hide Arm/Group Description:
Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Overall Number of Participants Analyzed 7 7 10 6 6
Measure Type: Number
Unit of Measure: participants
Any adverse event 7 7 10 6 6
≥Grade 3 adverse event 7 5 5 4 3
Grade 4 adverse event 1 2 3 2 1
Serious adverse event 3 2 4 1 2
Adverse event leading to discontinuation 0 0 1 0 1
Adverse event leading to death 0 0 0 0 1
3.Primary Outcome
Title Best Overall Response
Hide Description

Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:

Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time Frame Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Evaluable (EE) population consisted of all patients who completed at least 2 consecutive cycles of treatment, had at least 1 post-Baseline efficacy assessment performed, and did not have any major protocol violations.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Hide Arm/Group Description:
Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
Overall Number of Participants Analyzed 6 7 7 4 3
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 0 0 0
Partial Response 0 1 0 0 1
Stable disease 5 4 3 1 1
Progressive disease 1 2 4 3 1
Time Frame From the date of first dose to 30 days after last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Hide Arm/Group Description Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days. Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days. Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days. Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days. Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
All-Cause Mortality
Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   2/7 (28.57%)   4/10 (40.00%)   1/6 (16.67%)   2/6 (33.33%) 
Blood and lymphatic system disorders           
Anaemia NOS  1  0/7 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Thrombocytopenia  1  0/7 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders           
Myocardial infarction  1  0/7 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders           
Abdominal pain NOS  1  2/7 (28.57%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Constipation  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Gastric ulcer  1  0/7 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nausea  1  2/7 (28.57%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Small intestinal obstruction NOS  1  0/7 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/7 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vomiting NOS  1  2/7 (28.57%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
General disorders           
Asthenia  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Fatigue  1  0/7 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Sudden death  1  0/7 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hepatobiliary disorders           
Bile duct obstruction  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations           
Pneumonia NOS  1  0/7 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders           
Anorexia  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Hypercalcaemia  1  0/7 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/7 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Neck pain  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  0/7 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1 Dose Level 2 Dose Level 5 Dose Level 6 Dose Level 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   7/7 (100.00%)   10/10 (100.00%)   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders           
Anaemia NOS  1  3/7 (42.86%)  2/7 (28.57%)  1/10 (10.00%)  2/6 (33.33%)  2/6 (33.33%) 
Neutropenia  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  1/6 (16.67%)  2/6 (33.33%) 
Thrombocytopenia  1  4/7 (57.14%)  4/7 (57.14%)  1/10 (10.00%)  4/6 (66.67%)  3/6 (50.00%) 
Gastrointestinal disorders           
Abdominal distension  1  0/7 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Abdominal pain NOS  1  4/7 (57.14%)  3/7 (42.86%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Constipation  1  2/7 (28.57%)  5/7 (71.43%)  5/10 (50.00%)  3/6 (50.00%)  3/6 (50.00%) 
Diarrhoea NOS  1  1/7 (14.29%)  3/7 (42.86%)  2/10 (20.00%)  1/6 (16.67%)  3/6 (50.00%) 
Dyspepsia  1  1/7 (14.29%)  2/7 (28.57%)  1/10 (10.00%)  0/6 (0.00%)  1/6 (16.67%) 
Nausea  1  6/7 (85.71%)  7/7 (100.00%)  7/10 (70.00%)  5/6 (83.33%)  4/6 (66.67%) 
Reflux oesophagitis  1  2/7 (28.57%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vomiting NOS  1  5/7 (71.43%)  5/7 (71.43%)  7/10 (70.00%)  5/6 (83.33%)  5/6 (83.33%) 
General disorders           
Asthenia  1  2/7 (28.57%)  0/7 (0.00%)  2/10 (20.00%)  1/6 (16.67%)  1/6 (16.67%) 
Chest pain  1  0/7 (0.00%)  3/7 (42.86%)  2/10 (20.00%)  0/6 (0.00%)  0/6 (0.00%) 
Fatigue  1  6/7 (85.71%)  6/7 (85.71%)  9/10 (90.00%)  4/6 (66.67%)  1/6 (16.67%) 
Oedema peripheral  1  0/7 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pain NOS  1  3/7 (42.86%)  2/7 (28.57%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Performance status decreased  1  0/7 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pyrexia  1  0/7 (0.00%)  3/7 (42.86%)  0/10 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Infections and infestations           
Urinary tract infection NOS  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Investigations           
Aspartate aminotransferase increased  1  0/7 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Blood bilirubin increased  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Liver function test abnormal  1  2/7 (28.57%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders           
Anorexia  1  2/7 (28.57%)  4/7 (57.14%)  7/10 (70.00%)  4/6 (66.67%)  1/6 (16.67%) 
Hyperkalaemia  1  0/7 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  2/7 (28.57%)  3/7 (42.86%)  2/10 (20.00%)  2/6 (33.33%)  1/6 (16.67%) 
Back pain  1  1/7 (14.29%)  3/7 (42.86%)  2/10 (20.00%)  3/6 (50.00%)  1/6 (16.67%) 
Muscle cramp  1  1/7 (14.29%)  2/7 (28.57%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Musculoskeletal pain  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Myalgia  1  1/7 (14.29%)  1/7 (14.29%)  1/10 (10.00%)  1/6 (16.67%)  1/6 (16.67%) 
Pain in extremity  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders           
Dizziness  1  1/7 (14.29%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  3/6 (50.00%) 
Dysgeusia  1  1/7 (14.29%)  1/7 (14.29%)  4/10 (40.00%)  2/6 (33.33%)  1/6 (16.67%) 
Headache  1  2/7 (28.57%)  0/7 (0.00%)  2/10 (20.00%)  1/6 (16.67%)  0/6 (0.00%) 
Psychiatric disorders           
Anxiety  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Confusional state  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Depression  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Insomnia  1  2/7 (28.57%)  1/7 (14.29%)  2/10 (20.00%)  1/6 (16.67%)  1/6 (16.67%) 
Renal and urinary disorders           
Dysuria  1  0/7 (0.00%)  2/7 (28.57%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Pollakiuria  1  0/7 (0.00%)  2/7 (28.57%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  3/7 (42.86%)  2/7 (28.57%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Epistaxis  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  2/6 (33.33%)  2/6 (33.33%) 
Hiccups  1  0/7 (0.00%)  2/7 (28.57%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Rhinorrhoea  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Sinus congestion  1  1/7 (14.29%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders           
Rash NOS  1  0/7 (0.00%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders           
Deep vein thrombosis  1  1/7 (14.29%)  0/7 (0.00%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Hypertension NOS  1  0/7 (0.00%)  1/7 (14.29%)  0/10 (0.00%)  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene’s request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00379639    
Other Study ID Numbers: GPI-06-0003
First Submitted: September 20, 2006
First Posted: September 22, 2006
Results First Submitted: July 5, 2012
Results First Posted: August 13, 2012
Last Update Posted: October 30, 2019