EUCTR2007-005097-31-SE
Active, not recruiting
Not Applicable
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; And Pharmacogenetics Blood Sample Amendment 01.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with advanced metastatic colorectal cancer (MCRC)
- Sponsor
- Bristol Myers Squibb International Corporation
- Enrollment
- 133
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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