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

Merck Sharp & Dohme LLC10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

vorinostatDRUG

Parts I \& II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria (Parts I \& II): * Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2 * Patients Have Adequate Bone Marrow, Liver Function And Renal Function Exclusion Criteria (Parts I \& II): * Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy * Patients Have Uncontrolled Intercurrent Illness * Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman

Outcomes

Primary Outcomes

Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)

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.

Time frame: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)

Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)

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

Time frame: Day 1 to Day 28

Secondary Outcomes

Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])

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.

Time frame: Days 1 & 28 of Cycle 1

Part I: Maximum Drug Concentration (Cmax)

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.

Time frame: Days 1 & 28 of Cycle 1

Part I: Time at Which Cmax Occurs (Tmax)

Data from ClinicalTrials.gov

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