Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)

Phase 2

Completed

• Conditions: Myelodysplastic Syndromes; Hematologic Malignancies; Leukemia; Myeloid Metaplasia; Lymphoma
• Interventions: Drug: ridaforolimus

• Registration Number: NCT00086125
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.

Detailed Description

The primary objective of the trial is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies by evaluating the response rates as defined for the individual malignancy categories. Secondary objectives include evaluating time to disease progression, progression-free survival and duration of response; evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573; describing health-related quality of life measurements; and exploring the safety and tolerability of AP23573 at the specified dose level.

Protocol Outline: Open label, non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort. Each patient receives a fixed dose of AP23573 administered intravenously (IV) over 30 minutes daily for five days (QDx5) to be repeated every 2 weeks.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-06-24
• Study First Submitted QC: 2004-06-25
• Study First Posted: 2004-06-28
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ridaforolimus	AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

Primary Outcome Measures

Name	Time	Method
To assess efficacy of AP23573 in patients with relapsed or refractory hematologic malignancies.	Duration of study

Secondary Outcome Measures

Name	Time	Method
Evaluating time to progression, progression-free survival, duration of response and safety	Duration of study

Trial Locations

Locations (8)

University of Chicago Hospitals, Section of Hematology/Oncology; 🇺🇸 Chicago, Illinois, United States

The Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic; 🇺🇸 Durham, North Carolina, United States

Jeane's Hospital of TUHS; 🇺🇸 Philadelphia, Pennsylvania, United States

New York Presbyterian Hospital, Weill College of Cornell University; 🇺🇸 New York, New York, United States

Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place; 🇺🇸 St. Louis, Missouri, United States

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States