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A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment


Patients will be treated INC280 and gefitinib(250mg) daily. Dose escalation for INC280 will
be performed. Each cohort for the phase IB part will consist of 3 to 6 newly enrolled
patients. A twice daily administration of INC280 may be investigated if deemed appropriate
based on emerging results from ongoing clinical trials.


Inclusion Criteria:



- Documented EGFR mutation

- Documented c-MET amplification

- Prior clinical benefit on EGFR inhibitors and then subsequent progression

-≥ 18 year old

- Life expectancy of ≥ 3 months

- ECOG performance status ≤ 2

Exclusion Criteria:

- Unable to swallow tables once or twice daily

- Previous treatment with c-MET inhibitor

- Any unresolved toxicity form previous anticancer therapy greater than grade 1

- History of cystic fibrosis

- History of acute or chronic pancreatitis

- Unable to undergo MRI or CT sans

- 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-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase Ib: Frequency and characteristics of dose limiting toxicities (DLTs) to the

Outcome Description:

1 cycle= 28 days

Outcome Time Frame:

From date of treatment until DLT, up to 52weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

China: State Food and Drug Administration (SFDA)

Study ID:

CINC280X2202

NCT ID:

NCT01610336

Start Date:

April 2012

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • EGFR
  • c-MET
  • Lung cancer
  • Gefitinib
  • Erlotinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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