A clinical study with INC280 in combination with gefitinib in patients with non-small cell lung cancer

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002569-39-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-21
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

- Documented EGFR mutation
- Documented c-MET amplification
- Prior clinical benefit on EGFR inhibitors and then subsequent progression
- ? 18 years of age
- Life expectancy ?3 months
- ECOG performance status ? 2

Other protocol inclusion criteria may apply
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 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

- Unable to swallow tablets once or twice daily
- Previous treatment with a c-MET inhibitor
- Any unresolved toxicity from previous anticancer therapy greater than Grade 1
- history of cystic fibrosis
- history of acute or chronic pancreatitis
- Unable to undergo an MRI or CT scans
- Known history of HIV
- Undergone a bone marrow or solid organ transplant
- Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
- Pregnant or nursing

Other protocol exclusion criteria may apply

Study & Design

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