Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

Advanced Cancer Clinical Trial

Official title:

Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106626
• Other study ID #: 2005_006
• Secondary ID: MK0683-012
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2005
• Last updated: March 16, 2009
• Start date: August 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level		Cycle 1 (21 days)	Yes
Secondary	Safety and Tolerability as Measured by the Number of Participants With Disease Progression		Any time during 8 cycle treatment period through 30 days after.	Yes