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RET Inhibitor for Solid Cancers ((MARGARET) Trial)
(MARGARET) Trial Summary
This trial is testing a new drug, TAS0953/HM06, to see if it is safe and effective in treating patients with advanced solid tumors with RET gene abnormalities.
(MARGARET) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria below(MARGARET) Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.(MARGARET) Trial Design
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Who is running the clinical trial?
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- You have a disease that can be measured or seen on medical tests according to specific guidelines.I have an advanced solid tumor.My tests show RET-gene abnormalities.I have brain metastases but haven't had symptoms, and I haven't taken steroids or anticonvulsants for at least a week.I have advanced lung cancer with a RET gene mutation and have been treated with RET inhibitors.Criterion: You have non-small cell lung cancer with a specific genetic change called a RET gene fusion. You may also be eligible if you have a different type of advanced cancer with the same genetic change and have already tried other treatments. You should be in good overall health and have certain blood, liver, and kidney function. If you have brain or spinal cord tumors, they should not be causing symptoms or should be stable after treatment.My blood, liver, and kidney functions are all within normal ranges.My condition worsened after treatment or I can't receive standard treatments.Common Exclusion Criteria:
- You have received experimental or anticancer treatment in the last 5 drug half-lives before starting the study.
- You had major surgery within 4 weeks before starting the study or plan to have major surgery during the study.
- You had whole brain radiotherapy within 14 days or other palliative radiotherapy within 7 days before starting the study, and still have side effects from it.
- You have uncontrolled heart problems, high blood pressure, or a history of certain heart conditions.
- Your corrected QT interval is longer than 470 milliseconds, or you have a history of certain heart rhythm problems.
- You have taken strong CYP3A4 inhibitors within 1 week or strong CYP3A4 inducers within 3 weeks before starting the study.I am fully active or have some restrictions but can still care for myself.My cancer does not have mutations in EGFR, KRAS, ALK, HER2, ROS1, BRAF, or METex14.My cancer has RET gene changes found in a biopsy.You have a measurable disease according to RECIST 1.1.I have brain metastases but do not have any symptoms.
- Group 1: TAS0953/HM06 Phase 2
- Group 2: TAS0953/HM06 Phase 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any available vacancies for this clinical trial?
"That is correct, the online clinicaltrials.gov registry currently lists this trial as recruiting patients. This study was originally posted on December 16th 2020 and last updated on April 13rd 2022. At present, there are 9 different enrolment sites looking for a total of 202 participants."
Please give me the total number of participating facilities for this research project.
"Nine clinical trial sites are currently operational for this study, which include START Midwest - Cancer & Hematology Centers of Western Michigan in Grand Rapids, The Sarah Cannon Research Institute/Tennessee Oncology in Nashville, Chao Family Comprehensive Cancer Center in Orange, and 6 additional locations."
How many people are participating in this experiment?
"Yes, the information available on clinicaltrials.gov attests to this trial's activeness in recruiting patients. This study was first posted on December 16th 2020 and received its latest update on April 13th 2022. The 9 different enrolment locations are looking for a total of 202 participants."
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