Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus)

Not Applicable

Conditions: -C499 Malignant neoplasm of connective and soft tissue, unspecified
Malignant neoplasm of connective and soft tissue, unspecified
C499

Registration Number: PER-059-08

Lead Sponsor: Merck Sharp & Dohme Corp,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 11

Inclusion Criteria

• Documented histological diagnosis of soft tissue or bone sarcoma that has metastasized, except for certain histopathological subtypes of sarcomas for which experts recognize that they do not benefit from conventional chemotherapies or with characteristically different natural histories. See Appendix G for a list of excluded sarcoma subtypes.
• Complete response, partial response or continuous stable disease defined by RECIST guidelines for a minimum of 4 cycles (and a maximum of 12 months) of any prior cytotoxic chemotherapy of 1, 2 or 3 line for metastatic disease.
• Disease status (EE or better response) confirmed by a central review of the 2 most recent radiological evaluations (eg, CT or MRI) obtained with a minimum of 6 and a maximum of 10 weeks between studies.
• Patients with partial response or stable disease upon admission to the study must have at least one measurable or evaluable lesion defined according to the RECIST guidelines.
• Patients with metastatic bone sarcoma should have at least one measurable visceral lesion or have achieved a complete response of visceral metastasis.
• ECOO performance status of 0 or 1
• Male or female patients> 13 years of age (patients 13-17 years of age must weigh at least 100 lbs. (45.4 kg)). In regions where applicable local laws prohibit the recruitment of patients <18 years of age, only patients> 18 years of age will be eligible.
• Patients must have normal organ and marrow function as defined below: leukocytes> 3,000 uL, absolute neutrophil count> 1,500 / uL, platelets> 100,000 / uL, total bilirubin below the upper normal institutional limit ( unless the patient has Gilbert´s disease, in which case <1.5 x LNS), AST (SGOT) / ALT (SGPT) <2.5 X upper institutional limit (or <5 X LNS if there is presence of liver metastases), creatinine <1.5 X LNS for the institution (or calculated creatinine clearance> 50 mL / min / 1.73 m2)
• 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 contraceptive methods from the time of screening until 30 days after the last dose of study medication.
• Ability to understand and willingness to sign a written informed consent document
• Have completed 1, 2 or 3 line chemotherapy and received the last dose> 3 weeks before randomization
• Randomization and treatment should start <8 weeks after previous treatment

Exclusion Criteria

• Pregnant or lactating women
• Presence of brain metastases or in known or active CNS
• Previous treatment with rapamycin or rapamycin analogs, including AP23573
• Continuous toxicity associated with previous anticancer treatment> Grade 2 (excluding alopecia) according to the NCI standard terminology criteria
• Another primary malignancy in the last three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
• Known hypersensitivity Grade 3 or 4 to macrolide antibiotics (eg, clarithromycin, erythromycin, azithromycin)
• Concomitant treatment with drugs that induce or inhibit CYP3A. Patients must have stopped taking these medications> 2 weeks before the first dose of AP23573
• Uncontrolled significant cardiovascular disease
• Active infection that requires systemic treatment
• Known HIV infection
• Concurrent treatment with immunosuppressive agents apart from corticosteroids prescribed at stable doses for> 2 weeks before the first planned dose of study medication
• Inadequate recovery from any previous surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of the study medication (except minor procedures, eg central venous catheter placement)
• Presence of any life-threatening disease or organ or system dysfunction that, in the opinion of the investigator, could affect patient safety or interfere with the safety evaluation of the study medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Defined as the time from the date of randomization to the date of documented progressive illness, recurrence or death (whichever comes first)<br>Measure:Progression free survival<br>Timepoints:Until the date of documented progressive illness, recurrence or death (whichever comes first)<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Defined as the time from the randomization date to the date of death<br>Measure:General survival<br>Timepoints:Until the date of death<br>;<br>Outcome name:Defined as the best change in synthesis of white lesions from baseline to progression of the disease<br>Measure:Better response of white lesion<br>Timepoints:During the study<br>;<br>Outcome name:Clinical examination of signs and symptoms during the study<br>Measure:Changes in selected symptoms related to cancer<br>Timepoints:During the study<br>;<br>Outcome name:It will be evaluated through physical examination, intermediate clinical history and laboratory evaluations. Adverse events will be classified according to the NCI Common Terminology Criteria for Adverse Events<br>Measure:Safety and tolerability<br>Timepoints:During the study<br>

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