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

Lymphoma Clinical Trial

Official title:

Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771472
• Other study ID #: 0683-089
• Secondary ID: 2008_565
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2008
• Last updated: April 2, 2015
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Wada H, Tsuboi R, Kato Y, Sugaya M, Tobinai K, Hamada T, Shimamoto T, Noguchi K, Iwatsuki K. Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)	Yes
Primary	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	Day 1 to Day 28	Yes
Secondary	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.	Days 1 & 28 of Cycle 1	No
Secondary	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.	Days 1 & 28 of Cycle 1	No
Secondary	Part I: Time at Which Cmax Occurs (Tmax)	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.	Days 1 & 28 of Cycle 1	No
Secondary	Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)	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.	Days 1 & 28 of Cycle 1	No