Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Osteosarcoma

Metastases

Leiomyosarcoma

Sarcoma, Soft Tissue

Liposarcoma

Treatments

Drug: ridaforolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00093080

2004-002231-92 (EudraCT Number)

AP23573-04-202 (Other Identifier)

8669-018

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.

Enrollment

216 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients ≥15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups: Bone sarcomas, such as osteosarcoma and Ewings sarcoma; Leiomyosarcoma; Liposarcomas; Any other soft tissue sarcoma except gastrointestinal stromal tumors (GIST). Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months
Presence of at least one measurable lesion that: Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral computerized tomography (CT) scan (or otherwise at least twice the reconstruction interval for CT or magnetic resonance imaging [MRI] scans)
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Minimum life expectancy of 3 months
Adequate renal and hepatic function, as specified in the protocol
Adequate bone marrow function, as specified in the protocol
Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug
Able to understand and give written informed consent

Exclusion criteria

Women who are pregnant or lactating
Presence of brain metastases
Prior therapy with rapamycin, rapamycin analogues or tacrolimus
Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of ridaforolimus
Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by National Cancer Institute (NCI) toxicity criteria)
Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
Significant uncontrolled cardiovascular disease
Active infection requiring systemic therapy
Known human immunodeficiency virus (HIV) infection
Treatment with any investigational agent within 4 weeks prior to the first dose of ridaforolimus
Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for 2 weeks prior to first planned dose of study drug
Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of ridaforolimus
Presence of 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 evaluating the safety of the study drug