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 Inc0 个研究点目标入组 228 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
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
入选标准
- •Note: No upper age limit for this clinical trial, (indicated as 18 years
- •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:
- •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
- •3. Must be eligible for treatment with paclitaxel and carboplatin +/- bevacizumab
- •4. Must be at least 18 years of age
- •5. Must have stage â??wetâ?? 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
- •6. 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)
- •7. 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)
- •8. Measurable disease by the Response Evaluation Criteria in Solid Tumors
- •(RECIST) criteria must be present
- •9. ECOG performance status must be 0 or 1
- •10. Life expectancy of at least 3 months from the start of protocol therapy
- •(Cycle 1, Day 1)
- •11. Patient must be able to receive care as an outpatient at the time of entry
- •12. 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
- •13. 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].
- •14. Adequate renal function. Creatinine level must be no more than 2.25 mg/dl (200
- •Î¼mol/liter)
- •15. Women and men of child bearing/conceiving potential must be willing to use
- •adequate contraceptive procedures during the course of the study
- •16. 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
- •17. Must be willing and able, in the opinion of the investigator, to comply with the
- •protocol tests and procedures
- •18. 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
- •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
- •2. 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 â??wetâ?? IIIB/IV disease
- •qualifying the patient for the present study.
- •3. 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
- •4. 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
- •5. Women who are pregnant or breast feeding are excluded
- •6. Patients with active infections, including HIV disease
- •7. Patients with untreated hypo- or hyperthyroidism as assessed by screening TSH.
- •8. 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
- •9. 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.
- •10. Patients with uncontrolled or brittle diabetes
- •11. Patients with physiologic or psychological eating disorders
- •12. Patients with significant obesity, BMI 30 at screening
- •13. Patients receiving a concurrent investigational agent
- •14. Patients with known hypersensitivity to carboplatin or paclitaxel or any of their
- •components (e.g. cremophor EL)
研究者
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