CTRI/2011/091/000299已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC
Helsinn Therapeutics US Inc14 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2008年5月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 14
- 主要终点
- Changes from baseline in handgrip strength and body weight. Timeline: May 2008 to December 2009
研究概览
简要总结
The clinical study is being conducted in USA and India. It is currently recruiting patients across 27 sites participating in the study from USA. India is the only other participating country. Sponsor proposes to enroll up to 228 patients between two countries. This is a double-blind, parallel-group, placebo-controlled outpatient study. Patients will be randomized 1:1:1 to receive anamorelin HCl at 50 mg, 100 mg, or placebo daily for twelve weeks. A central randomization system will be used and eligible patients will be stratified based on concomitant use of bevacizumab (+/-).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Note: No upper age limit for this clinical trial, (indicated as 18 years and above) 1.Must have histologically or cytologically documented Non-Small Cell Lung Cancer (NSCLC) 2.Acceptable histologic forms of NSCLC are squamous, large cell, bronchioloalveolar, or adenocarcinoma including intermediate forms Protocol Amendment No 3, approval received dated 11th Feb 2010 and is uploaded in the approval field.
- •Inclusion Criteria:
- •Must have histologically or cytologically documented Non-Small Cell Lung Cancer (NSCLC)
- •Acceptable histologic forms of NSCLC are squamous, large cell, bronchioloalveolar, or adenocarcinoma including intermediate forms
- •Must be eligible for treatment with paclitaxel and carboplatin +/- bevacizumab
- •Must be at least 18 years of age
- •Must have stage “wet†IIIB disease (any T, N3, M0 or T4, any N, M0, with malignant pleural or pericardial effusion) or stage IV (any T, any N, M1) disease by AJCC criteria
- •Prior diagnostic or therapeutic surgery is allowed so long as the wound has fully healed the patient has fully recovered from the procedure and at least 3 weeks have elapsed from the procedure and the start (Cycle 1, Day 1) of protocol therapy (3-week recovery requirement does not apply to needle biopsy or other minimally invasive procedures such as chest tube placement or VATS pleurodesis)
- •Prior radiotherapy is allowed for local symptom palliation prior to the start of treatment so long as no more than 1/3rd of the marrow bearing bone has been radiated, the patient has fully recovered from the procedure and at least 3 weeks have elapsed from the procedure and the start of protocol therapy (see Appendix V)
- •Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria must be present
- •ECOG performance status must be 0 or 1
- •Life expectancy of at least 3 months from the start of protocol therapy (Cycle 1, Day 1)
- •Patient must be able to receive care as an outpatient at the time of entry
- •Adequate marrow function defined as an absolute neutrophil count (ANC) of 1,500/cmm or more without growth factor treatment, a platelet count of 150,000/cmm or more and a hemoglobin of at least 9 g/dL without transfusion or growth factor support
- •Adequate hepatic function.
- •Liver aminotransferases AST (SGOT) and ALT (SGPT) not more than 2.5-fold the upper limit of normal; total bilirubin not more than 1.5-fold the upper limit of normal.
- •(These values reflect the upper limit of CTC Grade-1 toxicity based on laboratory reference ranges) [Kratz 2004].
- •Adequate renal function.
- •Creatinine level must be no more than 2.25 mg/dl (200 μmol/liter)
- •Women and men of child bearing/conceiving potential must be willing to use adequate contraceptive procedures during the course of the study
- •Women of child bearing potential (e.g. not surgically sterilized or two years postmenopausal) must have a negative beta-hCG pregnancy test at study entry
- •Must be willing and able, in the opinion of the investigator, to comply with the protocol tests and procedures
- •Must be willing and able to give signed informed consent.
排除标准
- •1.Patients who have mesothelioma, small cell carcinoma or any histologic type not included in the inclusion criteria.
- •Mixed large and small cell histologies are not allowed 2.Patients with uncontrolled CNS metastases or receiving dexamethasone for CNS disease.
- •Minimal disease not requiring immediate treatment or not expected to need treatment in the next 2 months are allowed 3.Women who are pregnant or breast feeding are excluded 4.Patients receiving a concurrent investigational agent 5.Patients with any concomitant medical or psychiatric condition or social situation that would make it difficult to comply with protocol requirements, including the inability to comply with handgrip strength determinations in both hands.
- •Protocol Amendment No 3, approval received dated 11th Feb 2010 and is uploaded in the approval field.
- •Exclusion Criteria
- •Mixed large and small cell histologies are not allowed
- •Patients with prior chemotherapy for this disease.
- •Patients who received prior adjuvant chemotherapy for early stage disease or prior chemotherapy for Stage III disease and then have relapsed with Stage IV disease may participate provided that at least 4 weeks have lapsed since prior chemotherapy and the patient has not yet received their first dose of chemotherapy for the “wet†IIIB/IV disease qualifying the patient for the present study.
- •Patients with a prior malignancy (except for cervical cancer or basal cell carcinoma) treated at least 5 years before study entry and without evidence of recurrence since that time
- •Patients with uncontrolled CNS metastases or receiving dexamethasone for CNS disease.
- •Minimal disease not requiring immediate treatment or not expected to need treatment in the next 2 months are allowed
- •Women who are pregnant or breast feeding are excluded
- •Patients with untreated hypo- or hyperthyroidism as assessed by screening TSH.
- •Patients receiving strong CYP3A4 inhibitors (itraconazole, ketoconazole, or clarithromycin), megestrol acetate, anabolic steroids, high dose steroids (20 mg of prednisone/day equivalent or more) or any other agent to increase appetite or weight such as growth hormone (GH), insulin-like growth factor 1 (IGF-1), insulin like growth factor binding protein-3 (IGFBP-3), growth hormonereleasing hormone, or cannabinoids.
- •Patients must have discontinued these medications for at least 6 weeks prior to Cycle 1, Day 1 and throughout the study duration.
- •Patients receiving tube feedings or parenteral nutrition (either total or partial).
- •Patients must have discontinued these treatments for at least 6 weeks prior to Cycle 1, Day 1 and throughout the study duration.
- •Patients with physiologic or psychological eating disorders
- •Patients with known hypersensitivity to carboplatin or paclitaxel or any of their components (e.g. cremophor EL)
- •Patients with any concomitant medical or psychiatric condition or social situation that would make it difficult to comply with protocol requirements, including the inability to comply with handgrip strength determinations in both hands; for example, pre-existing neurological impairment.
- •Patients who do not meet or exceed the 7 kg handgrip strength threshold in each hand in at least one of three consecutive measurements in each hand at Screening (see Flowchart).
结局指标
主要结局
Changes from baseline in handgrip strength and body weight. Timeline: May 2008 to December 2009
时间窗: May 2008 to December 2009
次要结局
- Anamorelin pharmacokinetic data. Timeline: May 2008 to December 2009(May 2008 to December 2009)
研究者
研究点 (14)
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