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