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

NCT00771472 | Completed Phase 1 Results

• 2 other identifiers: 0683-0892008_565
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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)

• 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

Secondary Outcomes (4)

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

  Days 1 & 28 of Cycle 1

• Part I: Maximum Drug Concentration (Cmax)

  Days 1 & 28 of Cycle 1

• Part I: Time at Which Cmax Occurs (Tmax)

  Days 1 & 28 of Cycle 1

• Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)

  Days 1 & 28 of Cycle 1

Study Arms (1)

Vorinostat

EXPERIMENTAL

Drug: vorinostat

Interventions

vorinostat DRUG

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

Also known as: MK-0683, Zolinza

Vorinostat

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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. J Dermatol. 2012 Oct;39(10):823-8. doi: 10.1111/j.1346-8138.2012.01554.x. Epub 2012 Apr 16.

  PMID: 22506596 RESULT

MeSH Terms

Conditions

Lymphoma

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 13, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 21, 2015
• Results First Posted: July 4, 2012

Record last verified: 2015-04