Status:
TERMINATED
Study of Safety and Efficacy of INC280 and Cetuximab, in Adult c-MET Positive mCRC and HNSCC Patients After Progression on Cetuximab or Panitumumab Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Squamous Cell Carcinoma of Head and Neck (SCCHN)
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination was to be explor...
Eligibility Criteria
Inclusion
- Male or female aged ≥ 18 years
- Metastatic colorectal cancer or head and neck squamous cell carcinoma
- c-MET positive (defined by c-MET IHC intensity score +2 in ≥ 50% of tumor cells and MET gene copy number ≥ 5 by FISH or IHC intensity score +3 in ≥ 50% of tumor cells) and K/NRAS WT status for mCRC patients only
- At least one previous line of treatment for the metastatic disease and the last treatment must have included cetuximab or panitumumab. Documentation of clinical benefit and subsequent progression on cetuximab or panitumumab as the most recent line of treatment is required for patients in the expansion part
- Measurable disease as per RECIST v1.1
- ECOG performance status ≤ 2
Exclusion
- Prior treatment with c-MET/HGF inhibitors
- History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia)
- History of acute or chronic pancreatitis
- Active bleeding within 4 weeks prior to screening visit
- Symptomatic brain metastases
- Feeding tube dependence
- Not adequate hematologic, renal and hepatic function
Key Trial Info
Start Date :
July 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02205398
Start Date
July 28 2014
End Date
January 20 2017
Last Update
January 22 2019
Active Locations (15)
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1
Massachusetts General Hospital Head & Neck
Boston, Massachusetts, United States, 02114
2
Memorial Sloan Kettering MSKCC NY
New York, New York, United States, 10017
3
University of Utah / Huntsman Cancer Institute Onc Dept
Salt Lake City, Utah, United States, 84103
4
Novartis Investigative Site
Leuven, Belgium, 3000