A Blinded, Randomized, Phase 1/2 Study of Brivanib Alaninate vs. Placebo in Combination with Erbitux and Irinotecan in K-Ras wild type Subjects with Metastatic Colorectal Cancer. Revised Protocol 06 incorporating Protocol Amendment 09.+ Pharmacogenetics Blood Sample Amendment 01+ Amendment Number 05 - Site Specific (version 1.0, dated 11-Aug-08)

Bristol Myers Squibb International Corporation0 个研究点目标入组 133 人2008年7月8日

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暂无简介。

注册库

who.int

开始日期

2008年7月8日

结束日期

待定

最后更新

12年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\) Signed Written Informed Consent
•a) Voluntary signed and dated written informed consent form in accordance with regulatory and institutional guidelines obtained before the performance of any protocol\-related procedures not part of normal subject care.
•2\) Target Population
•a) Able to comply with visits/procedures required by protocol.
•b) Life expectancy at least 3 months.
•c) Subjects with histological or cytological confirmed diagnosis of metastatic CRC.
•d) Part 1: Subjects who have progressive or refractory disease after treatment with one or more chemotherapy regimens, not including adjuvant therapy.
•e) Part 2: Subjects who have progressive or refractory disease after treatment with only one chemotherapy regimen, not including adjuvant therapy.
•f) Subjects who have bi\-dimensionally measurable disease by CT or MRI
•g) Subjects in both parts of the study may have received a prior irinotecan or a prior Erbitux containing regimen, but they may not have received a prior regimen containing both irinotecan and Erbitux.

•1\) Sex and Reproductive Status
•a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to12 weeks after the last dose of investig product
•b) WOCBP using a prohibited contraceptive method
•c) Women who are pregnant or breastfeeding
•d) Women with a positive pregnancy test on enrollment or prior to investigational product administration
•e) Sexually active fertile men not using effective birth control if their partners are WOCBP
•2\) Target Disease Exceptions
•a) Subjects with known brain metastasis
•b) Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI
•3\) Medical History and Concurrent Diseases