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

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

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

Inclusion Criteria:

- histologically confirmed advanced solid tumors

- measurable or evaluable disease

- written informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria:

- Prior treatment with romidepsin or gemcitabine

- Prior chemotherapy treatment within 3 weeks prior to the first day of treatment or
prior treatment with an investigational agent within 4 weeks prior to the first day
of treatment. Patients must have recovered from all therapy-related toxicities
(Common Terminology Criteria grade ≤ 1)

- Prior radiotherapy within 4 weeks prior to the first day of treatment. Patients who
have not fully recovered or whose acute toxicity related to prior radiotherapy has
not returned to baseline are ineligible.

- Prior surgery within 3 weeks prior to the first day of treatment, excluding surgical
biopsies and port placements

- Concomitant use of any other anti-cancer therapy

- Concomitant use of any investigational agent

- Use of any investigational agent within 4 weeks of study entry

- Any known cardiac abnormalities, including congenital long QT syndrome, QTcF interval
>480 milliseconds, myocardial infarction within 12 months of study entry, coronary
artery disease (CAD), congestive heart failure (CHF), evidence of cardiac ischemia at
screening, known history of sustained ventricular tachycardia (VT), ventricular
fibrillation (VF), Torsade de Pointes, or cardiac arrest, hypertrophic cardiomegaly
or restrictive cardiomyopathy chronic hypertension, any cardiac arrhythmia requiring
anti-arrhythmic medication

- Serum potassium <3.8 mmol/L or serum magnesium <2.0 mg/dL (electrolyte abnormalities
can be corrected with supplementation to meet inclusion criteria)

- Concomitant use of drugs that may cause a prolongation of the QTc

- Concomitant use of CYP3A4 inhibitors

- Clinically significant active infection

- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

- Inadequate bone marrow or other organ function as evidenced by:

- Hemoglobin <9 g/dL (Transfusions and/or erythropoietin are permitted.)

- Absolute neutrophil count (ANC) ≤1.5 x 10^9 cells/L

- Platelet count <100 x 10^9 cells/L or platelet count <75 x 10^9 cells/L if bone
marrow disease involvement is documented

- Total bilirubin >2.0 x upper limit of normal (ULN)

- Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and
alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN
or >3.0 x ULN in the presence of demonstrable liver metastases

- Serum creatinine >2.0 x ULN

- Patients who are pregnant or breast-feeding

- Any significant medical or psychiatric condition that might prevent the patient from
complying with all study procedures

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Howard A. Burris, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

July 2008

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • advanced solid tumors
  • Pancreatic Neoplasms



Sarah Cannon Research InstituteNashville, Tennessee  37203