Head and neck squamous cell carcinoma. Colorectal cancer. MedDRA version: 17.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: INC280 200 mg
Product Code: INC280
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
CAS Number: INC280
Current Sponsor code: INC280
Other descriptive name: INC2
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged greater than or equal to 18 years. 2. Metastatic colorectal cancer or head and neck squamous cell carcinoma. 3. c-MET positive (defined by c-MET IHC intensity score +2 or +3 in greater than or equal to 50% of tumor cells) and K/NRAS-WT status for mCRC patients only. 4. 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 treatment is required for patients in the expansion part. 5. Measurable disease as per RECIST v1.1. 6. ECOG performance status ? 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Prior treatment with c-MET/HGF or EGFR inhibitors (with the exception of the last treatment). 2. History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia). 3. History of acute or chronic pancreatitis. 4. Active bleeding within 4 weeks prior to screening visit. 5. Symptomatic brain metastases. 6. Feeding tube dependence. 7. Not adequate hematologic, renal and hepatic function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the MTD and/or RDE of INC280 in combination with cetuximab in c-MET positive mCRC and HNSCC patients as measured by the incidence of DLTs in Cycle 1.;Secondary Objective: 1. To characterize the safety and tolerability of the INC280 and cetuximab combination as measured by the frequency and severity of AEs/SAEs and the frequency of dose interruptions and dose reductions in patients treated with the combination of INC280 and cetuximab. 2. To assess preliminary anti-tumor activity of the INC280 and cetuximab combination as measured by Overall Response Rate and Progression Free Survival in patients treated with the combination of INC280 and cetuximab. 3. To assess additional clinical activity of the INC280 and cetuximab combination as measured by Overall Survival for patients in the expansion part of the study. 4. To characterize the PK profile of INC280 with cetuximab combination as measured by time versus plasma concentration profiles and basic PK parameters of INC280.;Primary end point(s): Incidence of DLTs;Timepoint(s) of evaluation of this end point: Assessed during cycle 1 of treatment with INC280 and cetuximab | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Safety: Frequency and severity of AEs/SAEs Tolerability: Frequency of dose interruptions and dose reductions 2) ORR and PFS per response evaluation criteria in solid tumors (RECIST) v1.1 3) OS (only in Expansion part) 4) Plasma concentration versus time profiles and basic PK parameters of INC280;Timepoint(s) of evaluation of this end point: 1) Assessed from C1D1 until treatment discontinuation. 2) Assessed every 8 weeks from C1D1 up to the end of study. 3) Assessed every 12 weeks up to the end of study. 4) Assessed during the first 4 cycles of treatment. | — |
Countries
Belgium, Canada, China, France, Germany, Italy, Netherlands, Spain, United States
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmacéutica, S.A.
Outcome results
None listed