EUCTR2010-022240-21-HU进行中（未招募）不适用
A Phase 1b/2 Study of Carboplatin-Paclitaxel, with or without ISIS 183750 (an eIF4E Inhibitor), in Patients with Stage IV Non-Small Cell Lung Cancer
Isis Pharmaceuticals Inc.0 个研究点目标入组 118 人开始时间: 2011年5月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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
- •Patients with Stage IV NSCLC are eligible to be included in the study only if they meet all of the following
- •1. Provide written informed consent prior to screening.
- •2. Male or female patients, age = 18 years.
- •3. Histologically or cytologically confirmed diagnosis of NSCLC.
- •4. Stage IV disease (including patients with pleural effusion who were previously classified as Stage IIIB).
- •5. All of the following if patient has had prior radiation therapy:
- •a. Lesion(s) used for determination of response were not previously irradiated or have increased in size since the
- •completion of radiotherapy
- •b. The patient has recovered from any acute effects of the radiotherapy
- •c. Radiotherapy was completed at least 4 weeks prior to Screening.
- •6. Part 1: Have at least non-measurable evaluable disease (e.g., lesions which are smaller than the minimum size
- •required for measurability; other non-measurable lesions such as bone metastases, malignant pleural effusion)
- •Part 2: Have measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1
- •dimension (longest diameter to be recorded) as = 10 mm on cross-sectional imaging (where the CT slice
- •thickness is no greater than 5 mm) or at least 20 mm by standard techniques; positron emissions tomography
- •[PET] and ultrasound are not permitted methods for tumor measurements under this protocol. Consult RECIST
- •1.1 guidance for additional information (Appendix 5 and Eisenhauer et al., 2009)
- •7. Performance status of 0 or 1 on the ECOG Performance Status Scale.
- •8. Have an estimated life expectancy of at least 12 weeks.
- •9. Adequate organ function within 14 days prior to first study dose (ISIS 183750 or carboplatin/paclitaxel,
- •whichever occurs first) including the following:
- •a. Absolute neutrophil count (ANC)= 1.5 x 109/L
- •b. Platelet count =100 x 109/L
- •c. Hemoglobin =9 g/dL (=5.6 mmol/L). Patients may receive packed RBC transfusion to achieve this level at the discretion of the investigator.
- •d. Total bilirubin < 1.5 x upper limit of normal (ULN) unless elevated secondary to conditions such as Gilbert’s
- •e. Aspartate aminotransferase (AST) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)
- •f. Alanine aminotransferase (ALT) < 3 x ULN (< 5 x ULN in the presence of hepatic metastases)
- •g. Alkaline phosphatase < 3.0 x ULN
- •h. Calculated creatinine clearance = 60 mL/min per Cockcroft and Gault formula (see Appendix 7)
- •i.Serum albumin =3.0 g/dL
- •10. Satisfy one of the following:
- •a. Females: non-pregnant and non-lactating; surgically sterile, post-menopausal, or patient or partner compliant
- •with a reliable contraceptive regimen, as determined by Investigator, for 4 weeks prior to Screening. Patients of
- •reproductive potential must test negative for pregnancy at Screen and must agree to use a reliable method of birth control during the study and for the 10 weeks following the last dose of ISIS 183750.
- •b. Males: surgically sterile or patient or partner must agree to use a reliable contraceptive method, as determined by the Investigator during the study and for the 10 weeks following the last dose of ISIS 183750.
- •11. The patient is willing and able to comply with the study visit schedule and procedures, and has geographical proximity (Investigator’s discretion) that allows follow-up specified by the protocol.
- •12. For Part 1: have discontinued all prior chemotherapies, biological therapies, and other investigational
- •therapies for cancer for at lea
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1. Part 1: More than 2 prior chemotherapy or biological therapy regimens (approved or experimental) for
- •NSCLC, not counting adjuvant and neoadjuvant treatment. A regimen is defined as two or more consecutive
- •cycles of treatment.
- •Part 2: Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC including adjuvant
- •and neoadjuvant treatments
- •2. Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological
- •agents) before Screening or 5 half-lives of study agent, whichever is longer
- •3. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Brain imaging is
- •required for symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- •4. Patients with known pericardial effusion
- •5. Have active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with
- •the study (at the discretion of the Investigator)
- •6. Presence or history of malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin
- •cancer. In the case of other malignancies, patients may be considered for participation if the prior malignancies
- •were diagnosed and definitively treated at least five years previously with no subsequent evidence of recurrence.
- •7. Presence of an underlying disease state associated with active bleeding
- •8. Ongoing therapy with oral or parenteral anticoagulants (e.g., heparin, warfarin/coumadin). Low-dose
- •anticoagulants for maintenance of catheter patency and low dose aspirin (= 325 mg/day) and nonsteroidal
- •antiinflammatory
- •agents are not exclusionary.
- •9. Concurrent treatment with other anticancer drugs
- •10. Pre-existing peripheral neuropathy Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
- •10. Known history of HIV, HCV, or chronic HBV infection
- •11. Previous treatment with a therapeutic antisense oligonucleotide or siRNA
- •12. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device
- •13. Have any other medical conditions that in the opinion of the Investigator, would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study.
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