Trials / Terminated
TerminatedNCT03592641
Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer
A Phase 2 Study of Savolitinib in Subjects With MET Amplified Metastatic Colorectal Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Savolitinib | Given PO |
Timeline
- Start date
- 2019-07-25
- Primary completion
- 2021-07-31
- Completion
- 2021-12-30
- First posted
- 2018-07-19
- Last updated
- 2023-10-17
- Results posted
- 2023-08-08
Locations
33 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03592641. Inclusion in this directory is not an endorsement.