A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Colorectal Cancer; Non-Small-Cell Lung Carcinoma
Intervention: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) (Drug); Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
This is an investigational study to determine the response rate of relapsed/refractory
breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid
(SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response
evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and
tolerability of oral suberoylanilide hydroxamic acid.
Clinical Details
Official title: A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-Small Cell Lung Cancer.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
Secondary outcome: Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days.
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 breast adenocarcinoma,
colorectal carcinoma or non-small cell lung cancer
- Patients must have relapsed or refractory disease following at least one
chemotherapeutic treatment regimen.
- Has a measurable, positron emission tomography (PET) assessable lesion
- Adequate blood, liver, bone marrow 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.
Exclusion Criteria:
- Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
- Patient has had treatment with investigational agents within the last 30 days.
- Patient has active infection or had intravenous (IV) 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 lactating.
- Patient has allergy to any component of the study drug.
Locations and Contacts
Additional Information
Related publications: Vansteenkiste J, Cutsem EV, Dumez H, Chen C, Ricker JL, Randolph SS, Schöffski P. Early phase II trial of oral vorinostat in relapsed or refractory breast, colorectal, or non-small cell lung cancer. Invest New Drugs. 2008 Apr 19; [Epub ahead of print]
Starting date: December 2004
Last updated: May 7, 2008
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