Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03592641|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : September 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma Metastatic Colon Adenocarcinoma Metastatic Rectal Adenocarcinoma 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||Drug: Savolitinib||Phase 2|
I. To estimate the objective response rate (ORR) of savolitinib in patients with MET amplified metastatic colorectal cancer (CRC).
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Savolitinib in Subjects With MET Amplified Metastatic Colorectal Cancer|
|Actual Study Start Date :||January 30, 2019|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Treatment (savolitinib)
Patients receive savolitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall response rate [ Time Frame: Up to 1 year ]Defined as a complete response or partial response by Response Evaluation Criteria in Solid Tumors 1.1 criteria.
- Duration of response [ Time Frame: Up to 1 year ]Will be estimated using the Kaplan-Meier method.
- Progression free survival [ Time Frame: Up to 1 year ]Will be estimated using the Kaplan-Meier method.
- Incidence of adverse events [ Time Frame: Up to 1 year ]Adverse events will be described by grade, frequency, and attribution according to Common Terminology Criteria for Adverse Events 5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592641
|Principal Investigator:||John H Strickler||Duke University - Duke Cancer Institute LAO|