Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
NCT01719380
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- Metastatic colorectal cancer
- Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
- Life expectancy ≥ 3 months
- ECOG performance status ≤ 2
- Symptomatic or untreated leptomeningeal disease
- Symptomatic brain metastasis
- Patients with clinically manifested diabetes
- Acute or chronic pancreatitis
- Clinically significant cardiac disease
Other protocol-defined inclusion/exclusion criteria may apply.
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Descriptive Information | |||||||
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Brief Title ICMJE | Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer | ||||||
Official Title ICMJE | A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer | ||||||
Brief Summary | This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Colorectal Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 156 | ||||||
Original Estimated Enrollment ICMJE | 124 | ||||||
Actual Study Completion Date ICMJE | February 12, 2019 | ||||||
Actual Primary Completion Date | October 31, 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Norway, Spain, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01719380 | ||||||
Other Study ID Numbers ICMJE | CLGX818X2103 C4221002 ( Other Identifier: Alias Study Number ) 2012-002138-35 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |