A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 165
- 主要终点
- Tumor Response Rate (RR)
研究概览
简要总结
A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.
详细描述
This is a two part study to investigate the safety and anti-tumour effects of standard chemotherapy, plus an investigational drug (CDP791), in patients with advanced non small cell lung cancer.
In part one, patients receive carboplatin and paclitaxel chemotherapy together with one of 2 doses of CDP791. The main aim of this part is to investigate safety and tolerability of carboplatin/paclitaxel plus CDP791.
If part one confirms that the combination of drugs is safe and well tolerated, 156 patients will enter part 2. They will be randomized to receive either carboplatin/paclitaxel (C/P) alone, or C/P plus one of 2 doses of CDP791. The main aim of this part of the study is to compare the anti-tumor effects of CDP791 plus C/T with those of C/T alone. Participants will receive up to six cycles of chemotherapy with or without CDP791. Those whose disease stabilizes, or responds, will be eligible to continue to receive CDP791. Participants in the C/T alone arm whose disease progresses will be eligible to receive CDP791 monotherapy.
Participants will be followed up longterm, so that survival can be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma.
- •The subject must be aged 18 years or above.
- •The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months.
- •Subjects will have measurable disease.
- •The subject must be able to understand the information provided to them and to give written informed consent.
- •Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator.
- •Male subjects must be using a method of contraception judged reliable by the Investigator.
排除标准
- •Subjects with squamous cell lung carcinoma.
- •Subjects with lung lesions located centrally in the chest that involve major blood vessels.
- •Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more.
- •Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy.
- •Subjects known to be infected with hepatitis B or C virus or HIV 1 or
- •Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent).
- •Exclusion Criteria:
研究组 & 干预措施
Carboplatin/Paclitaxel
Carboplatin and paclitaxel alone.
干预措施: Carboplatin (Drug)
Carboplatin/Paclitaxel
Carboplatin and paclitaxel alone.
干预措施: Paclitaxel (Drug)
Carboplatin/Paclitaxel/CDP791 10mg
Carboplatin and paclitaxel plus CDP791 10mg/kg
干预措施: Carboplatin (Drug)
Carboplatin/Paclitaxel/CDP791 10mg
Carboplatin and paclitaxel plus CDP791 10mg/kg
干预措施: Paclitaxel (Drug)
Carboplatin/Paclitaxel/CDP791 10mg
Carboplatin and paclitaxel plus CDP791 10mg/kg
干预措施: CDP791 10mg/kg (Drug)
Carboplatin/Paclitaxel/CDP791 10mg
Carboplatin and paclitaxel plus CDP791 10mg/kg
干预措施: CDP791 20mg/kg (Drug)
Carboplatin/Paclitaxel/CDP791 20mg
Carboplatin and paclitaxel plus CDP791 20mg/kg
干预措施: Carboplatin (Drug)
Carboplatin/Paclitaxel/CDP791 20mg
Carboplatin and paclitaxel plus CDP791 20mg/kg
干预措施: Paclitaxel (Drug)
Carboplatin/Paclitaxel/CDP791 20mg
Carboplatin and paclitaxel plus CDP791 20mg/kg
干预措施: CDP791 10mg/kg (Drug)
Carboplatin/Paclitaxel/CDP791 20mg
Carboplatin and paclitaxel plus CDP791 20mg/kg
干预措施: CDP791 20mg/kg (Drug)
结局指标
主要结局
Tumor Response Rate (RR)
时间窗: 24 weeks
Participants are evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al; 2000). The tumor response rate is calculated as the total number of subjects whose best overall response is a complete response (CR)= disappearance of all target lesions; or a partial response (PR) = \>=30 % decrease in the sum of the longest diameter of target lesions, divided by the number of randomized subjects (RS): (CR + PR) / RS.
次要结局
- Progression Free Survival (PFS)(Up to 57 weeks)
- Time to Treatment Failure(Up to 57 weeks)
- Overall Survival(Up to 57 weeks)
- Duration of Overall Response(Up to 57 weeks)
- Time to Response(Week 24)