Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Gemcitabine

Romidepsin

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Participants were to receive 7, 10 or 12 mg/m\^2 of romidepsin intravenously on either Days 1, 8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28-day cycle, followed by 800 or 1000 mg/m\^2 of gemcitabine. Subsequent doses of both drugs were based on treatment-related toxicities. The planned duration of study therapy was 6 cycles or until disease progression occurred. Patients who responded could continue beyond 6 cycles until disease progression or until a withdrawal criterion was met.

7, 10 or 12 mg/m\^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle.

800 or 1000 mg/m\^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.

Howard A. Burris, M.D.

This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.

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

A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors.

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.

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.

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.

Celgene

Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.

Dose Level 1

Participants received romidepsin 7 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1, 8, and 15 every 28 days.

Dose Level 2

Participants received romidepsin 10 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.

Dose Level 5

Participants received romidepsin 10 mg/m\^2 plus gemcitabine 1000 mg/m\^2 on Days 1 and 15 every 28 days.

Dose Level 6

Participants received romidepsin 12 mg/m\^2 plus gemcitabine 800 mg/m\^2 on Days 1 and 15 every 28 days.

Dose Level 8

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black

Pakistani

Race/Ethnicity, Customized

United States

Region of Enrollment

Height

Weight

Body Surface Area (BSA)

Associate Director, Clinical Trials Disclosure

Safety population - all participants who received at least one dose of study drug.

Number of Participants With a Dose-limiting Toxicity (DLT)

Any adverse event

≥Grade 3 adverse event

Grade 4 adverse event

Serious adverse event

Adverse event leading to discontinuation

Adverse event leading to death

Number of Participants With Adverse Events (AEs)

Complete Response

Partial Response

Stable disease

Progressive disease

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.

Best Overall Response

Overall Study

Spots Global Cancer Trial Database for A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial