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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00126451 |
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.
Condition | Intervention | Phase |
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Breast Cancer Colorectal Cancer Non-Small-Cell Lung Carcinoma |
Drug: 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 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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. |
Estimated Enrollment: | 42 |
Study Start Date: | December 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_014, MK0683-011 |
Study First Received: | August 2, 2005 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00126451 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Thoracic Neoplasms Non-small cell lung cancer Digestive System Neoplasms Skin Diseases Gastrointestinal Diseases Vorinostat Colonic Diseases Breast Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Digestive System Diseases Respiratory Tract Diseases Lung Neoplasms Lung Diseases Gastrointestinal Neoplasms Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Breast Diseases Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |