Clinical trial NCT01353664: A Rollover Study for Patients Who Participated in Other Romidepsin Protocols
Official title: An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Cancer
Keywords: rollover protocol
romidepsin
Gloucester Pharmaceuticals
Celgene Corporation
continuing treatment
Lead sponsor: Celgene
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
First posted: 2011-05-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: London
country: United Kingdom
facility: Sarah Cannon Research UK
Study officials:
affiliation: Celgene Corporation
name: Ken Takeshita, MD
role: STUDY_DIRECTOR
References: