PER-059-08已完成未知
A Pivotal Trial to Determine the Efficacy and Safety of AP23573 (Ridaforolimus) when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 8 至 90（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone SarcomasPatients who have benefited from cytotoxic chemotherapy. Patients will have either metastatic soft-tissue or bone sarcoma, with histological category (soft-tissue or bone) as one of the baseline stratification factors. Impotantly, in this trial, bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver), or have achieved response of visceral metasrasis.MedDRA version: 9.1Level: LLTClassification code 10006008Term: Bone sarcoma NOSMedDRA version: 9.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasEUCTR2007-003462-18-BEARIAD Pharmaceuticals, Inc.705
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A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone SarcomasPatients who have benefited from cytotoxic chemotherapy. Patients will have either metastatic soft-tissue or bone sarcoma, with histological category (soft-tissue or bone) as one of the baseline stratification factors. Impotantly, in this trial, bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver), or have achieved response of visceral metasrasis.MedDRA version: 9.1Level: LLTClassification code 10006008Term: Bone sarcoma NOSMedDRA version: 9.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasEUCTR2007-003462-18-NLARIAD Pharmaceuticals, Inc.705
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A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone SarcomasEUCTR2007-003462-18-SKMerck Sharp & Dohme Corporation, a subsidiary of Merck & Co, Inc705