EUCTR2007-003462-18-SE进行中（未招募）不适用
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
Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co, Inc0 个研究点目标入组 675 人开始时间: 2007年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. See Attachment G for a list of excluded sarcoma sub-types.
- •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 at least the 2 most recent radiological evaluations (e.g., CT or MRI scans) obtained a minimum of 6 (± 1 week) and a maximum of 12 weeks (± 1 week) 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 protocol Attachment D)
- •5. Patients with only bone metastases are excluded.
- •6. ECOG performance status of 0 or 1 (see protocol 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/?L
- •? absolute neutrophil count ? 1,500/?L
- •? platelets ? 100,000/?L
- •? 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 having received the last dose ? 3 and ? 12 weeks (± 1 week) prior to randomization
- •13. Randomization and treatment to begin ? 12 weeks (± 1 week) following previous chemotherapy
- •14. No brain or CNS metastasis, unless successfully treated (i.e., controlled for > 3 months
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 549
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Women who are pregnant or lactating
- •2. Presence of known or active brain or CNS metastases, unless successfully treated (i.e., controlled for> 3 months)
- •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
研究者
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