Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)

Phase 1

Completed

• Conditions: Lymphoma
• Interventions: Drug: vorinostat

• Registration Number: NCT00771472
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-13
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2012-05-30
• Results First Submitted QC: 2012-05-30
• Results First Posted: 2012-07-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vorinostat	vorinostat	-

Primary Outcome Measures

Name	Time	Method
Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)	Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)	A laboratory AE is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.
Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)	Day 1 to Day 28	A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0): * Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC; * Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment; * Grade 4 neutropenia lasting at least 5 days; * Grade 4 thrombocytopenia; * Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator; * Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies

Secondary Outcome Measures

Name	Time	Method
Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])	Days 1 & 28 of Cycle 1	Blood samples taken as follows: Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.
Part I: Maximum Drug Concentration (Cmax)	Days 1 & 28 of Cycle 1	Blood samples taken as follows: Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.
Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)	Days 1 & 28 of Cycle 1	Blood samples taken as follows: Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.
Part I: Time at Which Cmax Occurs (Tmax)	Days 1 & 28 of Cycle 1	Blood samples taken as follows: Day 1 \& Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat.