Mesothelioma Related Clinical Trials:
Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer.
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Status: Active
Sponsors and Collaborators: Merck
Information provided by: Merck
Government Identifier: NCT00106626
Condition: Neoplasms; Mesothelioma; Non-Small-Cell Lung Carcinoma
Intervention: Drug: Suberoylanilide Hydroxamic Acid (SAHA)
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Purpose:
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.
| Study Type: |
Interventional |
| Study Design: |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
|
| Official Title: |
Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer. |
Further study details as provided by Merck:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) as measured by unacceptable toxicity. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: |
46 |
| Study Start Date: |
September 2005 |
| Estimated Study Completion Date: |
July 2008 |
| Arms |
Assigned Interventions |
| 1
vorinostat |
Drug: Suberoylanilide Hydroxamic Acid (SAHA)
Dose escalation study starting at vorinostat 200 mg b.i.d. capsules and rising up to vorinostat 400 mg b.i.d. capsules repeated 14 day treatment period in 21 day cycles. |
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Eligibility:
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
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
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Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106626
Locations
|
| United States, Nevada |
|
Call for Information |
|
Las Vegas, Nevada, United States, 89135 |
Sponsors and Collaborators
Investigators
|
| Study Director: |
Medical Monitor |
Merck |
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Additional Information:
| Responsible Party: |
Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: |
2005_006, MK0683-012 |
| First Received: |
March 28, 2005 |
| Last Updated: |
February 7, 2008 |
| ClinicalTrials.gov Identifier: |
NCT00106626 |
| Health Authority: |
United States: Food and Drug Administration |
Keywords provided by Merck:
| Advanced solid tumors including MPM and NSCLC |
|
Study placed in the following topic categories:
| Pemetrexed |
| Thoracic Neoplasms |
| Non-small cell lung cancer |
| Cisplatin |
| Lung Neoplasms |
| Lung Diseases |
|
|
| Mesothelioma |
| Adenoma |
| Carcinoma, Non-Small-Cell Lung |
| Suberoylanilide hydroxamic acid |
| Neoplasms, Glandular and Epithelial |
| Carcinoma |
|
Additional relevant MeSH terms:
| Mesothelioma |
| Anti-Inflammatory Agents |
| Anticarcinogenic Agents |
| Respiratory Tract Neoplasms |
| Neoplasms by Histologic Type |
| Molecular Mechanisms of Pharmacological Action |
| Neoplasms, Mesothelial |
| Antineoplastic Agents |
| Physiological Effects of Drugs |
| Enzyme Inhibitors |
|
|
| Protective Agents |
| Pharmacologic Actions |
| Neoplasms |
| Neoplasms by Site |
| Respiratory Tract Diseases |
| Sensory System Agents |
| Analgesics, Non-Narcotic |
| Therapeutic Uses |
| Anti-Inflammatory Agents, Non-Steroidal |
| Peripheral Nervous System Agents |
|
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