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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-28

Study Completion Date

2017-01-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of Head and Neck (SCCHN) Metastatic Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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c-MET positive mCRC and HNSCC

c-MET positive and K/NRAS WT mCRC and c-MET positive HNSCC patients

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No