Trial Outcomes & Findings for A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors (NCT NCT00379639)
NCT ID: NCT00379639
Last Updated: 2019-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
28 days
Results posted on
2019-10-30
Participant Flow
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.
Participant milestones
| Measure |
Dose Level 1
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
10
|
6
|
6
|
|
Overall Study
Efficacy Evaluable Population
|
6
|
7
|
7
|
4
|
3
|
|
Overall Study
Completed 6 Cycles of Therapy
|
4
|
2
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
2
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
9
|
6
|
6
|
Reasons for withdrawal
| Measure |
Dose Level 1
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
3
|
3
|
3
|
4
|
4
|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
Symptomatic Deterioration
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
3
|
0
|
0
|
Baseline Characteristics
A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=7 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
n=7 Participants
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
n=10 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
n=6 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
n=6 Participants
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 11.04 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 15.54 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 13.37 • n=21 Participants
|
58.3 years
STANDARD_DEVIATION 11.98 • n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
34 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Pakistani
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
36 participants
n=10 Participants
|
|
Height
|
169.3 cm
STANDARD_DEVIATION 9.52 • n=5 Participants
|
163.7 cm
STANDARD_DEVIATION 8.13 • n=7 Participants
|
170.9 cm
STANDARD_DEVIATION 10.33 • n=5 Participants
|
159.6 cm
STANDARD_DEVIATION 4.09 • n=4 Participants
|
164.9 cm
STANDARD_DEVIATION 8.71 • n=21 Participants
|
166.3 cm
STANDARD_DEVIATION 9.21 • n=10 Participants
|
|
Weight
|
79.8 kg
STANDARD_DEVIATION 20.54 • n=5 Participants
|
77.6 kg
STANDARD_DEVIATION 25.21 • n=7 Participants
|
73.1 kg
STANDARD_DEVIATION 12.58 • n=5 Participants
|
69.0 kg
STANDARD_DEVIATION 26.84 • n=4 Participants
|
61.7 kg
STANDARD_DEVIATION 27.56 • n=21 Participants
|
72.7 kg
STANDARD_DEVIATION 21.70 • n=10 Participants
|
|
Body Surface Area (BSA)
|
1.9 m^2
STANDARD_DEVIATION 0.28 • n=5 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.29 • n=7 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.19 • n=5 Participants
|
1.7 m^2
STANDARD_DEVIATION 0.23 • n=4 Participants
|
1.7 m^2
STANDARD_DEVIATION 0.35 • n=21 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.27 • n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Safety population - all participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Dose Level 1
n=7 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
n=7 Participants
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
n=10 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
n=6 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
n=6 Participants
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With a Dose-limiting Toxicity (DLT)
|
3 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From the date of first dose to 30 days after last dose (up to 236 days).Population: Safety population.
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.
Outcome measures
| Measure |
Dose Level 1
n=7 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
n=7 Participants
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
n=10 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
n=6 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
n=6 Participants
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
7 participants
|
7 participants
|
10 participants
|
6 participants
|
6 participants
|
|
Number of Participants With Adverse Events (AEs)
≥Grade 3 adverse event
|
7 participants
|
5 participants
|
5 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs)
Grade 4 adverse event
|
1 participants
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event
|
3 participants
|
2 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse event leading to discontinuation
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse event leading to death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).Population: 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.
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.
Outcome measures
| Measure |
Dose Level 1
n=6 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
n=7 Participants
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
n=7 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
n=4 Participants
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
n=3 Participants
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Best Overall Response
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Overall Response
Partial Response
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Best Overall Response
Stable disease
|
5 participants
|
4 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Best Overall Response
Progressive disease
|
1 participants
|
2 participants
|
4 participants
|
3 participants
|
1 participants
|
Adverse Events
Dose Level 1
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Dose Level 5
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Dose Level 6
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Level 8
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=7 participants at risk
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
n=7 participants at risk
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
n=10 participants at risk
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
n=6 participants at risk
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
n=6 participants at risk
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction NOS
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting NOS
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Asthenia
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Fatigue
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Sudden death
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Infections and infestations
Pneumonia NOS
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
Other adverse events
| Measure |
Dose Level 1
n=7 participants at risk
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 2
n=7 participants at risk
Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.
|
Dose Level 5
n=10 participants at risk
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 6
n=6 participants at risk
Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.
|
Dose Level 8
n=6 participants at risk
Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
57.1%
4/7 • From the date of first dose to 30 days after last dose.
|
57.1%
4/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
66.7%
4/6 • From the date of first dose to 30 days after last dose.
|
50.0%
3/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
57.1%
4/7 • From the date of first dose to 30 days after last dose.
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
71.4%
5/7 • From the date of first dose to 30 days after last dose.
|
50.0%
5/10 • From the date of first dose to 30 days after last dose.
|
50.0%
3/6 • From the date of first dose to 30 days after last dose.
|
50.0%
3/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
50.0%
3/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • From the date of first dose to 30 days after last dose.
|
100.0%
7/7 • From the date of first dose to 30 days after last dose.
|
70.0%
7/10 • From the date of first dose to 30 days after last dose.
|
83.3%
5/6 • From the date of first dose to 30 days after last dose.
|
66.7%
4/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting NOS
|
71.4%
5/7 • From the date of first dose to 30 days after last dose.
|
71.4%
5/7 • From the date of first dose to 30 days after last dose.
|
70.0%
7/10 • From the date of first dose to 30 days after last dose.
|
83.3%
5/6 • From the date of first dose to 30 days after last dose.
|
83.3%
5/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Asthenia
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Chest pain
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Fatigue
|
85.7%
6/7 • From the date of first dose to 30 days after last dose.
|
85.7%
6/7 • From the date of first dose to 30 days after last dose.
|
90.0%
9/10 • From the date of first dose to 30 days after last dose.
|
66.7%
4/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Pain NOS
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Performance status decreased
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Infections and infestations
Urinary tract infection NOS
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Investigations
Liver function test abnormal
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
57.1%
4/7 • From the date of first dose to 30 days after last dose.
|
70.0%
7/10 • From the date of first dose to 30 days after last dose.
|
66.7%
4/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
50.0%
3/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
50.0%
3/6 • From the date of first dose to 30 days after last dose.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
40.0%
4/10 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
20.0%
2/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
33.3%
2/6 • From the date of first dose to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
28.6%
2/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
10.0%
1/10 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Vascular disorders
Deep vein thrombosis
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
|
Vascular disorders
Hypertension NOS
|
0.00%
0/7 • From the date of first dose to 30 days after last dose.
|
14.3%
1/7 • From the date of first dose to 30 days after last dose.
|
0.00%
0/10 • From the date of first dose to 30 days after last dose.
|
16.7%
1/6 • From the date of first dose to 30 days after last dose.
|
0.00%
0/6 • From the date of first dose to 30 days after last dose.
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER