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PKMYT1 inhibitor
RP-6306 for Advanced Cancer (MINOTAUR Trial)
Phase 1
Waitlist Available
Research Sponsored by Repare Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed advanced solid tumors resistant or refractory to standard treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months
Awards & highlights
MINOTAUR Trial Summary
This trial is testing a new drug to see if it is safe and effective against advanced solid tumors.
Who is the study for?
Adults over 18 with advanced solid tumors like colorectal, gastrointestinal, or esophageal cancer that's getting worse despite treatment. They must be able to perform daily activities with ease or only have minor limitations (ECOG score of 0-1), and women who can have children need a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing RP-6306 combined with FOLFIRI chemotherapy in patients with certain advanced solid tumors. It aims to find the safest dose, see how well it works against the cancer, and figure out the best dosage schedule.See study design
What are the potential side effects?
Possible side effects include those commonly associated with chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Specific side effects of RP-6306 are not detailed but may include typical reactions to oral cancer drugs.
MINOTAUR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has not responded to standard treatments.
Select...
I am fully active or can carry out light work.
Select...
My cancer is advanced or has spread, and recent scans show it's getting worse.
MINOTAUR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with of treatment-related adverse event data per CTCAE v5.0 criteria and frequency of dose limiting toxicities, to determine safety and tolerability of RP-6306 in combination with FOLFIRI.
To identify a maximum tolerated dose (MTD)
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC) from time 0 to 8 hours post dose
Best percent change in tumor size from baseline
Minimum blood plasma concentration (Cmin) will be observed directly from data
+2 moreMINOTAUR Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1: RP-6306 in combination with FOLFIRI Dose EscalationExperimental Treatment1 Intervention
RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)
Find a Location
Who is running the clinical trial?
Repare TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,024 Total Patients Enrolled
Nathan HawkeyStudy ChairRepare RX
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow or keep down pills.I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.I have not had major surgery in the last 4 weeks.My advanced cancer has not responded to standard treatments.I don't have any health issues that would affect the study or stop me from fully participating.I do not have any active, uncontrolled infections including HBV, HCV, HIV, or AIDS.My high blood pressure is not under control.My liver is not working well.I have brain metastases that are not under control and cause symptoms.I have not had serious heart problems in the last 6 months.I am fully active or can carry out light work.I can provide tumor tissue or am willing to undergo a biopsy if it's safe.I am 18 years old or older.My cancer is advanced or has spread, and recent scans show it's getting worse.My blood and organ tests are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still spots available for the trial to be filled by participants?
"The trial, which had its inception on the 9th of August 2022 and was recently updated on the 3rd of November, is currently recruiting participants as reported by clinicaltrials.gov."
Answered by AI
What is the upper limit of individuals enrolled in this clinical experiment?
"The clinical trial necessitates the enrollment of 104 candidates that fulfill all criteria. Potential participants can join this study at various locations, including Participating Site #1001 in Houston Texas and Participating site #1013 in Salt Lake City Utah."
Answered by AI
How have patients responded to the use of RP-6306 as an oral PKMYT1 inhibitor?
"Limited evidence of the safety and efficacy of RP-6306 (oral PKMYT1 inhibitor) has been gathered, so it received a score of 1."
Answered by AI
In what scenarios is RP-6306 (oral PKMYT1 inhibitor) typically utilized?
"RP-6306 (a type of oral PKMYT1 inhibitor) is most often prescribed for rectal carcinoma, but other malignancies such as colorectal carcinoma, ovarian cancer, and sarcomas can also be treated with this drug."
Answered by AI
What further research has been done on RP-6306 as an oral PKMYT1 inhibitor?
"Currently, there are 507 active clinical trials exploring the effectiveness of RP-6306 (oral PKMYT1 inhibitor) with 143 in Phase 3. Most occur at Woolloongabba, Queensland but can be found across 24448 locations worldwide."
Answered by AI
Are there any establishments administering this trial in the local area?
"As of right now, 7 sites are open to enrollment for this trial. These locations include Houston, Salt Lake City, and Toronto as well as 4 other cities. To minimize travel expenses, it is best that you select the nearest facility if you decide to participate in this study."
Answered by AI
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