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Kinase Inhibitor
BOS172738 for Non-Hematologic Cancers
Phase 1
Waitlist Available
Research Sponsored by Boston Pharmaceuticals
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 a minimum of approximately 3 months
Awards & highlights
Study Summary
This trial will study the safety and if it is tolerated when given to patients with advanced solid tumors that have a RET gene alteration. They will also study what the maximum tolerated dose is.
Eligible Conditions
- Advanced Non-Hematologic Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a minimum of approximately 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a minimum of approximately 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of BOS172738
Number of participants with any TEAE leading to study drug discontinuation
Number of participants with any non-serious TEAE
+4 moreSecondary outcome measures
Duration of Complete Response (DoCR)
Duration of Response (DoR)
Objective Disease Control Rate (ODCR)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BOS172738Experimental Treatment1 Intervention
In Part A (dose escalation), participants with advanced solid tumors with rearranged during transfection (RET) gene alterations will receive oral BOS172738 at a starting dose of 10 milligrams (mg) once daily in each 28-day cycle. In Part B (dose expansion), participants with RET gene-fusion non-small cell lung cancer (NSCLC), with RET gene-mutant medullary thyroid cancer (MTC), and with RET gene-altered advanced tumors or NSCLC/MTC with prior specific RET gene-targeted therapy will be enrolled in Cohorts 1, 2, and 3, respectively, and will receive oral BOS172738 once daily in each 28-day cycle at the recommended Phase 2 dose (RP2D) established in Part A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BOS172738
2018
Completed Phase 1
~120
Find a Location
Who is running the clinical trial?
Boston PharmaceuticalsLead Sponsor
11 Previous Clinical Trials
645 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced severe stomach bleeding, ulcers, or holes in your stomach in the past year before starting the study drug.You have had a stroke or brain-related injury in the past 6 months.You have had or currently have another type of cancer, apart from the ones being studied.You are currently receiving treatment for your cancer.
Research Study Groups:
This trial has the following groups:- Group 1: BOS172738
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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