Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)
A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
2 other identifiers
interventional
57
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2004
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 24, 2004
CompletedFirst Posted
Study publicly available on registry
June 28, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedAugust 19, 2015
August 1, 2015
2 years
June 24, 2004
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess efficacy of AP23573 in patients with relapsed or refractory hematologic malignancies.
Duration of study
Secondary Outcomes (1)
Evaluating time to progression, progression-free survival, duration of response and safety
Duration of study
Study Arms (1)
1
EXPERIMENTALAP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
Interventions
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
Eligibility Criteria
You may qualify if:
- Male or female patients ≥ 18 years of age
- Patients must have histologically-confirmed diagnoses of relapsed or refractory hematologic malignancy as specified in the protocol
- Patients must have an ECOG performance status of 0 to 2
- Patients must have adequate renal and liver function as demonstrated by laboratory values performed within 5 days, inclusive, prior to administration of the first dose of AP23573
- Patients must be able to understand and give written informed consent
You may not qualify if:
- Women who are pregnant or lactating
- Patients may not have had cytotoxic chemotherapy or radiotherapy within 14 days prior to study entry
- Patients may not receive any investigational anti-cancer agent while on this study or within 14 days prior to the first dose of AP23573
- Patients with known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug formulation
- Patients with known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
- Patients with significant uncontrolled cardiovascular disease
- Patients with known HIV infection
- Patients with any uncontrolled infection
- Patients receiving immunosuppressive agents other than prescribed corticosteroids
- Patients who have had prior therapy with rapamycin, any rapamycin analog or tacrolimus
- Patients with inadequate recovery from any prior surgical procedure or patients having undergone any major surgical procedure within 14 days prior to the first dose of AP23573
- Patients with any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
- Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
- Patients with another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinomas in situ)
- Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Ariad Pharmaceuticalscollaborator
Study Sites (8)
University of Chicago Hospitals, Section of Hematology/Oncology
Chicago, Illinois, 60637, United States
Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place
St Louis, Missouri, 63110, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
New York Presbyterian Hospital, Weill College of Cornell University
New York, New York, 10021, United States
Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic
Durham, North Carolina, 27705, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Jeane's Hospital of TUHS
Philadelphia, Pennsylvania, 19111, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Rizzieri DA, Feldman E, Dipersio JF, Gabrail N, Stock W, Strair R, Rivera VM, Albitar M, Bedrosian CL, Giles FJ. A phase 2 clinical trial of deforolimus (AP23573, MK-8669), a novel mammalian target of rapamycin inhibitor, in patients with relapsed or refractory hematologic malignancies. Clin Cancer Res. 2008 May 1;14(9):2756-62. doi: 10.1158/1078-0432.CCR-07-1372.
PMID: 18451242RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank Haluska, M.D., Ph.D.
Ariad Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2004
First Posted
June 28, 2004
Study Start
June 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
August 19, 2015
Record last verified: 2015-08