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Tyrosine Kinase Inhibitor

Savolitinib for Rectal Cancer

Phase 2
Waitlist Available
Led By John H Strickler
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until documented progression of disease (up to 4 months)
Awards & highlights

Study Summary

This trial studies savolitinib for MET amplified colorectal cancer. Savolitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Rectal Cancer
  • Colon Cancer
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until documented progression of disease (up to 4 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until documented progression of disease (up to 4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Secondary outcome measures
Months of Progression-Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (savolitinib)Experimental Treatment1 Intervention
Patients receive savolitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Savolitinib
2019
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,148 Total Patients Enrolled
John H StricklerPrincipal InvestigatorDuke University - Duke Cancer Institute LAO
4 Previous Clinical Trials
430 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants will this clinical trial accommodate?

"At the moment, this trial is not enrolling patients. The research was first uploaded on January 30th 2019 and last modified on September 16th 2022. However, there are currently 2149 clinical trials admitting individuals with unresectable rectal adenocarcinoma and 17 Savolitinib studies that require participants."

Answered by AI

What is the geographic reach of this clinical trial?

"This research is being conducted across 30 sites, with the main clinical centres located in Chicago, Illinois; Mineola, New york; and Torrington Connecticut."

Answered by AI

Has any similar research been conducted prior to this endeavor?

"Since 2014, Savolitinib has undergone extensive research. The initial trial was funded by AstraZeneca and involved 999 participants. After its successful completion in 2014, the drug entered into Phase 2 trials and eventually gained approval from medical authorities. As of today, there are 17 active clinical trials for this medication that span 415 cities across 34 nations."

Answered by AI

Are there any unoccupied positions available in this research project?

"This trial is not currently accepting patients; its initial posting was on January 30th 2019 and it most recently underwent an update on September 16th 2022. For individuals looking for other trials, there are 2149 active studies with participants affected by unresectable rectal adenocarcinoma and 17 that involve Savolitinib as a treatment option."

Answered by AI

What adverse effects might be associated with Savolitinib usage?

"Savolitinib has been rated a 2 due to the lack of efficacy data and only preliminary safety evidence available."

Answered by AI

Has Savolitinib been the subject of any previous research studies?

"At present, 17 Savolitinib trials are ongoing with 5 studies in Phase 3. Of these, several take place in Westerville, Ohio while the 1156 other locations span across the world."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What portion of applicants met pre-screening criteria?
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer
2019. "Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03592641.
~1 spots leftby Apr 2025
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