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Safety Study of AP23573 in Patients With Advanced, Refractory or Recurrent Malignancies (8669-013)(COMPLETED) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety Study of AP23573 in Patients With Advanced, Refractory or Recurrent Malignancies (8669-013)(COMPLETED)

A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Daily x 5 Administration of AP23573, an mTOR Inhibitor, in Patients With Refractory or Advanced Malignancies

NCT00060645•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The primary objectives of the study are to determine the safety, tolerability, and MTD of AP23573, when administered once daily for 5 days to be repeated every 2 weeks (two 2-week courses equals 1 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 daily for 5 days to be repeated every 2 weeks. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•(Patients must meet each of the following criteria to be eligible for participation in the study).
•Male or female patients, ≥ 18 years of age.
•Patients with a documented measurable or evaluable malignancy, including myeloma or lymphoma, that is recurrent, advanced, or metastatic.
•Patients with disease that is currently refractory to, or not amenable to, standard therapy.
•Patients with disease that is currently not amenable to surgical intervention.
•Patients with Karnofsky performance status of ≥ 70% (ECOG performance status of 0 or 1) and an anticipated life expectancy of ≥ 3 months.
•Patients either not of childbearing potential, or agreeing to use a medically effective method of contraception.
•Patients with the ability to understand and give written informed consent.
•Patients with known HIV infection.
•Patients with any active infection.
+13 more criteria

Exclusion Criteria

•(Patients meeting any of the following criteria are ineligible for participation in the study)
•Women who are pregnant or lactating.
•Patients with primary CNS malignancies. Patients with leukemia, any form.
•Patients with certain hematologic abnormalities.
•Patients with certain serum chemistry abnormalities at baseline.
•Patients with known or suspected hypersensitivity to either drugs formulated with polysorbate 80 (Tween 80) or any other excipient contained in the test drug formulation.
•Patients with known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin).
•Patients with significant cardiovascular disease.

Locations (1)

Cancer Therapy and Research Center, University of Texas Health Center at San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

May 1, 2003

Primary Completion Date

May 1, 2006

Completion Date

February 1, 2009

Last Updated

August 27, 2015

Enrollment

ACTUAL participants

Conditions

TumorsLymphomaMultiple Myeloma

Interventions

ridaforolimus

DRUG

DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study

NCT01247597

Pleuropulmonary BlastomaCystic Nephroma+3 more

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study of AP23573 in Patients With Advanced, Refractory or Recurrent Malignancies (8669-013)(COMPLETED)

Inclusion Criteria

Exclusion Criteria

DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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