Savolitinib in Treating Patients With MET Amplified Metastatic or

Status Terminated

Clinical Trial Summary

This phase II trial studies how well savolitinib works in treating patients with MET amplified colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Savolitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To estimate the objective response rate (ORR) of savolitinib in patients with MET amplified metastatic colorectal cancer (CRC). SECONDARY OBJECTIVES: I. To describe the clinical activity (duration of response, progression free survival [PFS]) of savolitinib in patients with MET amplified metastatic CRC. II. To describe the toxicities of savolitinib in patients with MET amplified metastatic CRC. III. To explore the effect of RAS mutation status on response to savolitinib. IV. To explore any correlation between tissue and blood based biomarkers and clinical outcomes. OUTLINE: Patients receive savolitinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks thereafter for up to 2 years. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Colonic Neoplasms
Colorectal Carcinoma
Colorectal Neoplasms
Metastatic Colon Adenocarcinoma
Metastatic Rectal Adenocarcinoma
Rectal Neoplasms
Stage III Colon Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IIIA Colon Cancer AJCC v8
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Colon Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Colon Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8
Stage IV Colon Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage IVA Rectal Cancer AJCC v8
Stage IVB Colon Cancer AJCC v8
Stage IVB Rectal Cancer AJCC v8
Stage IVC Colon Cancer AJCC v8
Stage IVC Rectal Cancer AJCC v8
Unresectable Colon Adenocarcinoma
Unresectable Rectal Adenocarcinoma

Clinical Trial Details

NCT number	NCT03592641
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Terminated
Phase	Phase 2
Start date	July 25, 2019
Completion date	December 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms