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| Sponsor: | Ariad Pharmaceuticals |
|---|---|
| Information provided by: | Ariad Pharmaceuticals |
| 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| 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 |
| Estimated Enrollment: | 48 |
| 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
| Study ID Numbers: | AP23573-02-101 |
| Study First Received: | May 8, 2003 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00060632 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced, refractory or recurrent solid tumors |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |