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An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols

Phase 2
18 Years
Not Enrolling
Lymphoma, Cancer

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Trial Information

An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols

Subjects must have previously participated in a Romidepsin study sponsored by Gloucester
Pharmaceuticals of Celgene Corporation.

Inclusion Criteria

Inclusion Criteria

1. Previously participated in and fulfilled the inclusion and exclusion criteria in one
of the romidepsin clinical trials: GPI-06-0002, ROMI-ADVM-001, ROMI-ADVM-002.
Additional studies added at the discretion of the medical monitor of the study

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

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 subjects should use contraception during the treatment
period and for at least 3 months thereafter. Female subjects 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. Subjects who are pregnant or breast-feeding.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Ken Takeshita, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

October 2012

Related Keywords:

  • Lymphoma
  • Cancer
  • rollover protocol
  • romidepsin
  • Gloucester Pharmaceuticals
  • Celgene Corporation
  • continuing treatment
  • Lymphoma



Florida Cancer Specialists Fort Myers, Florida  33901
Sarah Cannon Research Institute Nashville, Tennessee  37203