Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced C... | NCT00091559

Studies
Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)

NCT00091559

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Apr 5, 2017Actual

Enrollment

74Actual

Phase

Phase 2

Conditions

Cutaneous T-cell Lymphoma
Sezary Syndrome
Mycosis Fungoides

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004_015

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2005Actual

Primary Completion Date

Nov 23, 2005Actual

Completion Date

Mar 13, 2006Actual

First Submitted Date

Sep 10, 2004

First Submission Date that Met QC Criteria

Sep 13, 2004

First Posted Date

Sep 14, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 5, 2017Actual

Description Module

Brief Summary

A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate in patients with progressive, persistent, or recurrent disease.

Secondary Outcomes

Measure	Description	Time Frame
Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher)
Age: over 18 years of age
Have the ability to swallow capsules.
You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment.
Patients also require adequate heart, liver, and kidney function.

Exclusion Criteria:

Pregnant and nursing women and those with known allergy to the study drug are excluded from this study.
Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy.
Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17577020	Background	Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. doi: 10.1200/JCO.2006.10.2434. Epub 2007 Jun 18.
18483262

ID	Term
D016410	Lymphoma, T-Cell, Cutaneous
D012751	Sezary Syndrome
D009182	Mycosis Fungoides

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

ID	Term
D000077337	Vorinostat
D000081206	Duration of Therapy

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds