Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Rectal Adenocarcinoma
- Colorectal Carcinoma
- Stage IVC Colon Cancer AJCC v8
- Metastatic Colon Adenocarcinoma
- Stage III Colon Cancer AJCC v8
- Stage IVC Rectal Cancer AJCC v8
- Stage IV Colon Cancer AJCC v8
- Stage IVA Colon Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
- Stage IIIA Colon Cancer AJCC v8
- Stage IIIA Rectal Cancer AJCC v8
- Unresectable Rectal Adenocarcinoma
- Stage IV Rectal Cancer AJCC v8
- Stage IVB Rectal Cancer AJCC v8
- Unresectable Colon Adenocarcinoma
- Stage IVA Rectal Cancer AJCC v8
- Stage IIIB Colon Cancer AJCC v8
- Stage IIIB Rectal Cancer AJCC v8
- Stage IVB Colon Cancer AJCC v8
- Stage IIIC Colon Cancer AJCC v8
- Stage IIIC Rectal Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03592641
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: John H Strickler Duke University - Duke Cancer Institute LAO
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