Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neoplasms; Mesothelioma; Non-Small-Cell Lung Carcinoma
Intervention: Suberoylanilide Hydroxamic Acid (SAHA) (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Maximum tolerated dose (MTD) as measured by unacceptable toxicity.
Secondary outcome: Assess the safety and tolerability after 14 consecutive day administration followed by 7 days of rest in repeated 21 day cycles as measured by disease progression or unacceptable toxicity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which
pemetrexed/cisplatin is acceptable treatment but has yet been previously treated with
systemic therapy or has failed standard first-line therapy
- 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 should not have failed more than 1 prior treatment regimen
- 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
Locations and Contacts
Call for Information, Las Vegas, Nevada 89135, United States
Additional Information
Starting date: September 2005
Ending date: July 2008
Last updated: February 7, 2008
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