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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907738
• Other study ID #: 0683-007
• Secondary ID: 2009_595
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2009
• Last updated: May 5, 2015
• Start date: August 2005
• Est. completion date: June 2010

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00588055

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 adva — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes