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| Sponsor: | Merck |
|---|---|
| Collaborator: |
Ariad Pharmaceuticals |
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00060632 |
Purpose
Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of AP23573 in patients with refractory or recurrent malignancies, including myeloma and lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors Lymphoma Multiple Myeloma |
Drug: ridaforolimus |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of AP23573, an mTOR Inhibitor, in Patients With Refractory or Advanced Malignancies |
| Enrollment: | 46 |
| Study Start Date: | April 2003 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
The primary objectives of the study are to determine the safety, tolerability, and MTD of AP23573 when administered once weekly for 4 weeks (4 week cycle). The secondary objectives of the study are to characterize the pharmacokinetic profile of AP23573, to evaluate potential pharmacodynamic markers of AP23573, and to obtain preliminary information on the antineoplastic activity of AP23573.
Protocol Outline: This is a dose-escalation study. Patients receive AP23573 over 30 minutes by intravenous infusion once weekly for 8 weeks (two 4-week cycles). If tolerated, a total of at least 2 cycles will be administered (8-week treatment period). Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(Patients must meet each of the following criteria to be eligible for participation in the study).
Exclusion Criteria:
(Patients meeting any of the following criteria are ineligible for participation in the study)
Drugs and Other Treatments to be Excluded (Either during or within 4 weeks prior to study entry, unless otherwise noted)
Contacts and Locations
More Information
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00060632 History of Changes |
| Other Study ID Numbers: | AP23573-02-101 |
| Study First Received: | May 8, 2003 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced, refractory or recurrent solid tumors |
|
Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Sirolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |