A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

NCT ID: NCT01353664

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-01
• Study Completion Date: 2012-09-05

Brief Summary

This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

Detailed Description

Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.

Conditions

Lymphoma; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Romidepsin

This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.

Group Type: EXPERIMENTAL

Romidepsin

Intervention Type: DRUG

The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.

Interventions

Romidepsin

The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.

Intervention Type: DRUG

Other Intervention Names

Istodax®, ROMI

Eligibility Criteria

Exclusion Criteria

2. Physician believes continued romidepsin treatment is of benefit to participant.

3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.

4. Able to adhere to the study visit schedule and other protocol requirements.

5. Negative urine or serum pregnancy test for females of child bearing potential; and

6. All females of child bearing potential must use an effective method of contraception (an intrauterine contraceptive device [IUCD] or double contraceptive method using condoms and a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male participants should use contraception during the treatment period and for at least 3 months thereafter. Female participants should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives. An in vitro binding assay determined that romidepsin competes with β-estradiol for binding to estrogen receptors.

1. Concomitant use of drugs that may cause a significant prolongation of the corrected measurement of the time between the start of cardiac Q wave and the end of the T wave (QTc) .

2. Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications.

3. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.

4. Prior chemotherapy or radiotherapy or any investigational agent after the last dose of romidepsin from the preceding romidepsin study.

5. Participants who are pregnant or breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ken Takeshita, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

Florida Cancer Specialists

Sarasota, Florida, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Sarah Cannon Research UK

London, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

2010-023040-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ROMI-ADVM-004

Identifier Type: -

Identifier Source: org_study_id