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

NCT ID: NCT00907738

Last Updated: 2015-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vorinostat

Group Type EXPERIMENTAL

vorinostat

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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MK-0683

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 19951879 (View on PubMed)

Other Identifiers

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2009_595

Identifier Type: -

Identifier Source: secondary_id

0683-007

Identifier Type: -

Identifier Source: org_study_id

NCT00588055

Identifier Type: -

Identifier Source: nct_alias

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