A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas - ND
- Conditions
- Metastatic Soft-Tissue or Bone SarcomasMedDRA version: 9.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas
- Registration Number
- EUCTR2007-003462-18-IT
- Lead Sponsor
- ARIAD PHARMACEUTICALS,INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 705
1.Documented histologic diagnosis of soft-tissue or bone sarcoma that has metastasized, with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapies or with distinctly different natural histories. 2.Ongoing complete response, partial response or stable disease as defined by RECIST guidelines after a minimum of 4 cycles (and maximum of 12 months) of any one of 1st, 2nd or 3rd line of prior cytotoxic chemotherapy for metastatic disease. 3.Disease status (SD or better response) confirmed by a central review of the most recent 2 consecutive radiological evaluations (e.g., CT or MRI scans) obtained a minimum of 6 and a maximum of 10 weeks apart. 4.Patients with partial response or stable disease at study entry must have least one measurable or evaluable lesion as defined by RECIST guidelines (see Attachment D) 5.Patients with metastatic bone sarcoma must have at least one measurable visceral lesion or have achieved a complete response of visceral metastasis. 6.ECOG performance status of 0 or 1 (see Attachment A) 7.Male or female patients ≥ 13 years of age (patients 13-17 years of age must weigh at least 100lbs. (45.4 kg)). In regions where applicable local law prohibits enrollment of patients <18 years of age, only patients ≥18 years of age will be eligible. 8.Patients must have normal organ and marrow function as defined below: leukocytes ≥ 3,000/µL absolute neutrophil count ≥ 1,500/µL platelets ≥ 100,000/µL total bilirubin below institutional upper limit of normal (unless patient has Gilbert?s disease in which case ≤1.5 x ULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (or ≤ 5 x ULN if liver metastases are present) creatinine ≤1.5 X ULN for the institution (or calculated creatinine clearance ≥ 50 mL/min/1.73 m2) 9.Serum cholesterol ≤ 350 mg/dL and triglycerides ≤ 400 mg/dL 10.Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control from time of screening until 30 days after the last dose of the study drug 11.Able to understand and willing to sign a written informed consent document 12.Completed 1st, 2nd or 3rd line chemotherapy and have received last dose ≥ 3 weeks prior to randomization 13.Randomization and treatment to begin ≤ 8 weeks following previous treatment
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Women who are pregnant or lactating 2.Presence of known or active brain or CNS metastases 3.Prior therapy with rapamycin or rapamycin analogs, including AP23573 4.Ongoing toxicity associated with prior anticancer therapy ≥ Grade 2 (excluding alopecia) according NCI common terminology criteria 5.Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ) 6.Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin) 7.Concomitant treatment with medications that induce or inhibit CYP3A. Patients should be off these medications ≥ 2 weeks prior to the first dose of AP23573 8.Significant uncontrolled cardiovascular disease 9.Active infection requiring systemic therapy 10.Known HIV infection 11.Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study drug 12.Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of study drug (with the exception of minor procedures, e.g., central venous access port placement) 13.Presence of any life-threatening illness or organ system dysfunction which, in the option of the Investigator, would either compromise the patient?s safety or interfere with evaluating the safety of the study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare progression-free survival (PFS) of patients who have achieved complete response, partial response or stable disease following 1st, 2nd or 3rd line chemotherapy when treated with AP23573 versus placebo.;Primary end point(s): Progression-free survival (PFS), defined as the time from the date of randomization to the date of documented progressive disease or death (whichever occurs first);<br> Secondary Objective: To compare the overall survival (OS) of patients when treated with AP23573 versus placebo<br> To compare the best target lesion response of patients receiving AP23573 versus placebo<br> To assess changes in cancer-related symptoms in those patients treated with AP23573 compared to those treated with placebo<br> To determine the safety and tolerability of AP23573<br>
- Secondary Outcome Measures
Name Time Method