Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00086125
Other study ID # 8669-024
Secondary ID AP23573-04-201
Status Completed
Phase Phase 2
First received June 24, 2004
Last updated August 18, 2015
Start date June 2004
Est. completion date June 2006

Study information

Verified date August 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria (Patients must meet each of the following criteria to be eligible for participation in the trial):

- 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

Exclusion Criteria (Patients meeting any of the following criteria are ineligible for participation in the study):

- 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

Drugs and Other Treatments to be Excluded (The following drugs and other treatments are not permitted for patients enrolling in the study, either during or within two weeks prior to the first dose of AP23573, unless otherwise specified):

- Chemotherapeutic agents with the following exception that therapy with nitrosoureas (including generics) cannot be given within six weeks prior to the first dose of AP23573

- Other antineoplastic agents

- Immunotherapy (including vaccines) or biological response modifier therapy

- Systemic hormonal therapy with exceptions as specified in the protocol

- Herbal preparations or related OTC preparations containing herbal ingredients (e.g., St John's Wort)

- Radiotherapy for the primary malignancy

- Any other investigational agent during the course of the trial should be discussed with the Sponsor prior to use

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ridaforolimus
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

Locations

Country Name City State
United States Gabrail Cancer Center Canton Ohio
United States University of Chicago Hospitals, Section of Hematology/Oncology Chicago Illinois
United States Morris Cancer Center - Duke University Medical Center, Adult Bone Marrow Transplant Clinic Durham North Carolina
United States MD Anderson Cancer Center Houston Texas
United States The Cancer Institute of New Jersey New Brunswick New Jersey
United States New York Presbyterian Hospital, Weill College of Cornell University New York New York
United States Jeane's Hospital of TUHS Philadelphia Pennsylvania
United States Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp. Ariad Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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 refr — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To assess efficacy of AP23573 in patients with relapsed or refractory hematologic malignancies. Duration of study No
Secondary Evaluating time to progression, progression-free survival, duration of response and safety Duration of study Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05540340 - A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant Phase 1
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Completed NCT00001512 - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Completed NCT01410630 - FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
Active, not recruiting NCT04270266 - Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT01949883 - A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma Phase 1
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Completed NCT04434937 - Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) Phase 2
Completed NCT01855750 - A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma Phase 3
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Terminated NCT00775268 - 18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma Phase 1/Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Terminated NCT00014560 - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Active, not recruiting NCT03936465 - Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer Phase 1