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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Experimental: 1
vorinostat (Suberoylanilide Hydroxamic Acid [SAHA])
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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).
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies
- Has at least 1 measurable lesion
- Has adequate blood, liver, and kidney functions
- Has not received any chemotherapy for at least 4 weeks prior to entry in this study
- Agrees to take adequate measures to prevent pregnancy as outlined in the protocol
Exclusion Criteria:
- Patient has been treated with other investigational agents with a similar anti-tumor mechanism
- Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months
- Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy
- Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
- Patient has HIV, hepatitis B or hepatitis C infection
- Patient is pregnant or breast feeding
- Patient has allergy to any component of the study drugs
- Patient has history of GI (gastrointestinal) surgery or conditions

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 LLC |
Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
ClinicalTrials.gov Identifier: | NCT00106626 |
Other Study ID Numbers: |
2005_006 MK0683-012 |
First Posted: | March 29, 2005 Key Record Dates |
Results First Posted: | April 22, 2009 |
Last Update Posted: | April 22, 2009 |
Last Verified: | March 2009 |
Advanced solid tumors including MPM and NSCLC |
Neoplasms Pemetrexed Vorinostat Antineoplastic Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Histone Deacetylase Inhibitors |