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

Stopped early · Phase 1

Conditions studied: Squamous Cell Carcinoma of Head and Neck (SCCHN), Metastatic Colorectal Cancer

In brief

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 explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients were to receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no scheduled break between cycles. The trial was terminated because of difficulties in identifying patients who met the eligibility criteria.

Key facts

Study ID

NCT02205398

Run by

Novartis Pharmaceuticals

People needed

13

Starts

2014-07-28

Expected to finish

2017-01-20

Last updated by the study team

2019-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital Head & Neck — Boston, Massachusetts, United States
• Memorial Sloan Kettering MSKCC NY — New York, New York, United States
• University of Utah / Huntsman Cancer Institute Onc Dept — Salt Lake City, Utah, United States
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Ancona, AN, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain

Full record on ClinicalTrials.gov

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