Study of Vorinostat (MK0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) Patients (0683-103)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00875056
First received: April 2, 2009
Last updated: May 26, 2011
Last verified: May 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 2, 2009 | ||||
| Last Updated Date | May 26, 2011 | ||||
| Start Date ICMJE | April 2009 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Overall Response Rate [ Time Frame: 21 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00875056 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Time to event efficacy endpoints 2)Any clinical or laboratory adverse experiences [ Time Frame: 21 Months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Vorinostat (MK0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) Patients (0683-103) | ||||
| Official Title ICMJE | A Phase II Study of MK0683 in Patients With Relapsed / Refractory Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) | ||||
| Brief Summary | This study evaluates safety and tolerability of MK0683 and efficacy of MK0683 in patients with relapsed and/or refractory FL. Exploratory purpose of this study is to evaluate efficacy of MK0683 in patients with relapsed and/or refractory other Indolent B-NHL or MCL. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Drug: vorinostat
MK0683 (200 mg capsule) Oral, twice daily (400 mg/day) for Day 1 through 14 of a 21 day cycle |
||||
| Study Arm (s) | Experimental: 1
vorinostat
Intervention: Drug: vorinostat |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 54 | ||||
| Estimated Completion Date | January 2014 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 20 Years to 74 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00875056 | ||||
| Other Study ID Numbers ICMJE | 2009_570, MK0683-103 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Merck | ||||
| Verification Date | May 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||