A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

Celgene

Status and phase: Completed; Phase 2

Conditions: Lymphoma; Cancer

Treatments: Drug: Romidepsin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353664

ROMI-ADVM-004

2010-023040-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Previously participated in and fulfilled the inclusion and exclusion criteria in one of the romidepsin clinical trials: ROMI-ADVM-001 (NCT01324310), ROMI-ADVM-002 (NCT01324323). Additional studies added at the discretion of the medical monitor of the study
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.

Exclusion Criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Romidepsin

Experimental group

Description:

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

Treatment:

Drug: Romidepsin