Clinical Trial: A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer

Brief Summary:

Background:

  • Papillary RCC is the second most common histologic subtype of kidney cancer, accounting for approximately 10-15% of cases
  • Type 1 papillary RCC occurs in both sporadic and hereditary forms, which are histologically identical. Non familial type 1 papillary RCC can present as both solitary renal tumors and as bilateral, multifocal disease
  • There are no standard agents of proven efficacy for patients with advanced papillary

RCC.

  • Patients with disease localized to the kidney are managed surgically while patients with advanced/unresectable disease are usually managed in the community with VEGF pathway antagonists or mTOR inhibitors.
  • Activating mutations of MET were identified in the germline of affected HPRC patients, who have a predilection for the development of bilateral, multifocal type 1 papillary RCC. Somatic MET mutations have been found in a subset of patients with non-inherited, sporadic papillary renal carcinoma
  • The investigational agent INC280 is a selective MET inhibitor lacking activity against the VEGF pathway
  • This is a proof-of-concept study using INC280 in patients with papillary RCC to test the idea that effectively blocking the HGF/MET pathway will lead to clinical activity in patients with papillary renal cell cancer

Objectives:

Primary Objective:

-To determine the overall response rate (RECIST 1.1) in patients with papillary renal cell carcinoma treated