Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00106626|
Recruitment Status : Completed
First Posted : March 29, 2005
Results First Posted : April 22, 2009
Last Update Posted : April 22, 2009
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
vorinostat (Suberoylanilide Hydroxamic Acid [SAHA])
Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin
Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).
- Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level [ Time Frame: Cycle 1 (21 days) ]MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.
- Safety and Tolerability as Measured by the Number of Participants With Disease Progression [ Time Frame: Any time during 8 cycle treatment period through 30 days after. ]Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106626
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|