An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)

NCT ID: NCT00097929

Last Updated: 2017-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-01

Study Completion Date

2006-07-31

Brief Summary

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A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.

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Detailed Description

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Conditions

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B-cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
* Stable disease or better for at least 3 months on most recent treatment
* Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
* Adequate blood testing, liver, and kidney function as required by the study.
* Eligible subjects will allow tissue samples to be examined and stored.

Exclusion Criteria

* Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
* Patient should not have failed more than 3 prior treatment regimens.
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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Crump M, Coiffier B, Jacobsen ED, Sun L, Ricker JL, Xie H, Frankel SR, Randolph SS, Cheson BD. Phase II trial of oral vorinostat (suberoylanilide hydroxamic acid) in relapsed diffuse large-B-cell lymphoma. Ann Oncol. 2008 May;19(5):964-9. doi: 10.1093/annonc/mdn031. Epub 2008 Feb 21.

Reference Type BACKGROUND
PMID: 18296419 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis Links

View Document

Other Identifiers

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MK0683-013

Identifier Type: -

Identifier Source: secondary_id

2004_029

Identifier Type: -

Identifier Source: secondary_id

0683-013

Identifier Type: -

Identifier Source: org_study_id

NCT00124631

Identifier Type: -

Identifier Source: nct_alias

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