A Rollover Study for Patients Who Participated in Other R... | NCT01353664

NCT01353664

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2010-023040-32	EudraCT Number

Status Module

Name	Class
Celgene Corporation	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Romidepsin	Experimental	This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.	Drug: Romidepsin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Romidepsin	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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
Physician believes continued romidepsin treatment is of benefit to participant.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Able to adhere to the study visit schedule and other protocol requirements.
Negative urine or serum pregnancy test for females of child bearing potential; and
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

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) .
Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications.
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.
Prior chemotherapy or radiotherapy or any investigational agent after the last dose of romidepsin from the preceding romidepsin study.
Participants who are pregnant or breast-feeding.

Name	Affiliation	Role
Ken Takeshita, MD	Celgene Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Florida Cancer Specialists		Sarasota	Florida	34232	United States
Sarah Cannon Research Institute

Arm/Group Information

ID	Title	Description
FG000	ROMI 4	Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	ROMI 4	Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Summary of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.	Safety Population = Participants who received at least one dose of study drug.	Posted		Number		Participants		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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ROMI 4	Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA V 15.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Fatigue	General disorders	MedDRA V 15.0	Systematic Assessment

Title	Organization	Phone	Extension	Email
Anne McClain	Celgene Corporation	1-888-260-1599		clinicaltrialdisclosure@celgene.com

ID	Term
D008223	Lymphoma
D009369	Neoplasms

ID	Term
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
C087123	romidepsin

ID	Title	Description
OG000	ROMI 4	Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.