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
| Status: | Terminated |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | July 28, 2014 |
| End Date: | January 20, 2017 |
A Phase Ib, Open-label, Multicenter, Dose Escalation and Expansion Study, to Evaluate the Safety, Pharmacokinetics and Activity of INC280 in Combination With Cetuximab in c-MET Positive CRC and HNSCC Patients Who Have Progressed After Anti-EGFR Monoclonal Antibody Therapy.
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.
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.
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
We found this trial at
4
sites
Salt Lake City, Utah 84103
Principal Investigator: Sunil Sharma
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Boston, Massachusetts 02114
Principal Investigator: Lori J. Wirth
Phone: 617-643-1735
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