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

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentTemporarily closed18 and overCINC280X2104
NCI-2014-02359, 2014-000579-20, NCT02205398

Trial Description

Summary

This is 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

will be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on

cetuximab or panitumumab treatment. The dose escalation part will be guided by a Bayesian

Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC

patients who have progressed on cetuximab or panitumumab treatment will 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 will receive INC280 on a continuous bid

dosing regimen and cetuximab every week. A treatment cycle is defined as 28 days with no

scheduled break between cycles.

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Novartis Pharmaceuticals Corporation

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT02205398

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.