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NCT02019693 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02019693: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02019693 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02019693, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Background: * Papillary Renal Cell Cancer (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 vascular endothelial growth factor (VEGF) pathway antagonists or mechanistic target of rapamycin (mTOR) inhibitors. * Activating mutations of mesenchymal epithelial transition (MET) were identified in the germline of affected hereditary papillary renal cancer (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 Capmatinib (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 hepatocyte growth factor (HGF)/MET pathway will lead to clinical activity in patients with papillary renal cell cancer Objectives: Primary Objective: -To determine the overall response rate (Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in patients with papillary renal cell carcinoma treated with single agent INC280 Eligibility: * Diagnosis of hereditary papillary renal carcinoma (HPRC) or sporadic papillary renal cell carcinoma (RCC) * Patients with bilateral multifocal disease can have tumors localized to the kidney or have metastatic disease * Patients with sporadic papillary RCC (but without multifocal d
Interventions
- DRUG INC280
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-01-24 |
| Est. Completion | 2021-12-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02019693
The ClinicalTrials.gov registry entry for NCT02019693 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INC280 is the first listed.
NCT02019693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02019693 about?
NCT02019693 is a clinical study titled "A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer". Background: * Papillary Renal Cell Cancer (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 ...
What is the current status of trial NCT02019693?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-01-24. Estimated completion is 2021-12-17.
What interventions are being tested in trial NCT02019693?
The interventions under investigation include: INC280 (DRUG).
Who is sponsoring clinical trial NCT02019693?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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