A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)

NCT00907738 | Completed Phase 2 Results

• 2 other identifiers: 0683-0072009_595
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With a Serious Drug-related Adverse Event (AE)

  A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.

  From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)

Study Arms (1)

Vorinostat

EXPERIMENTAL

Drug: vorinostat

Interventions

vorinostat DRUG

All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.

Also known as: MK-0683

Vorinostat

Eligibility Criteria

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

You may qualify if:

• Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
• Patient did not withdraw from the base protocol
• Patient agrees to practice effective birth control during the study

You may not qualify if:

• Patient is receiving other standard and/or investigational anticancer therapy
• Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Duvic M, Olsen EA, Breneman D, Pacheco TR, Parker S, Vonderheid EC, Abuav R, Ricker JL, Rizvi S, Chen C, Boileau K, Gunchenko A, Sanz-Rodriguez C, Geskin LJ. Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma. Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. doi: 10.3816/CLM.2009.n.082.

  PMID: 19951879 RESULT

MeSH Terms

Interventions

Vorinostat

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Non-serious adverse events were only collected if they caused drug interruption, discontinuation, or dose reduction.

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: August 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 21, 2015
• Results First Posted: July 14, 2011

Record last verified: 2015-05