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
Detailed 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
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: Overall response rate [ Time Frame: 4-5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Progression-free survival, overall survival, disease control rate and duration of response, tolerability [ Time Frame: 4-5 years ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: December 20, 2013
Date Started: December 13, 2013
Date Completion: January 1, 2019
Last Updated: May 12, 2017
Last Verified: September 27, 2016