A study with INC280 in combination with cetuximab in selected patients with colorectal or head and neck cancer who have progressed on prior therapy

Phase 1

• Conditions: Head and neck squamous cell carcinomaColorectal cancer; MedDRA version: 17.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000579-20-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-30
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 or +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 treatment is required for patients in the expansion part
• Measurable disease as per RECIST v1.1
• 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

• Prior treatment with c-MET/HGF or EGFR inhibitors (with the exception of the last treatment)
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified