Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00093080
First received: September 30, 2004
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leiomyosarcoma Liposarcoma Osteosarcoma Sarcoma, Soft Tissue Metastases |
Drug: ridaforolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of AP23573, An mTOR Inhibitor, in Patients With Advanced Sarcoma |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST) [ Time Frame: Day 1 up to 4 years or discontinuation from study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to Tumor Progression [ Time Frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Day 1 to the date of death, or the date of last contact (up to 4 years) ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) ] [ Designated as safety issue: No ]
- Number of participants experiencing adverse events [ Time Frame: From first dose up to 30 days after last dose (up to 1 year) ] [ Designated as safety issue: Yes ]
- Number of participants who discontinued study drug due to adverse events [ Time Frame: From first dose up to the last dose (up to 1 year) ] [ Designated as safety issue: Yes ]
- Mean ridaforolimus blood levels within 5 minutes post intravenous infusion [ Time Frame: Day 1 and Day 5 of Cycle 1 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Mean Expression Level of Nine Signaling Proteins [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
| Enrollment: | 216 |
| Study Start Date: | October 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ridaforolimus
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
|
Drug: ridaforolimus
12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks
Other Names:
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00093080 History of Changes |
| Other Study ID Numbers: | MK-8669-018, 2004-002231-92, AP23573-04-202 |
| Study First Received: | September 30, 2004 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Metastatic and/or unresectable soft tissue or |
Additional relevant MeSH terms:
|
Leiomyosarcoma Liposarcoma Neoplasm Metastasis Osteosarcoma Sarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Adipose Tissue Neoplastic Processes Pathologic Processes Neoplasms, Bone Tissue |
Neoplasms, Connective Tissue Sirolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013