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CDK2 Inhibitor
BLU-222 for Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Endometrial and gastric cancer that has progressed after at least 2 prior therapies (including one prior platinum therapy)
Advanced solid tumors that has progressed beyond standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 43 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and works well against cancer cells.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including breast cancer, ovarian cancer, endometrial cancer, and stomach cancer that have worsened despite standard treatments. Participants must not be in a health crisis due to their tumor or have serious heart issues or uncontrolled infections. Women of childbearing potential and men must agree to use effective contraception.Check my eligibility
What is being tested?
The study is testing BLU-222's safety and effectiveness against various cancers. It's an early-phase trial where patients will receive BLU-222 alone or combined with other drugs like Carboplatin, Ribociclib, or Fulvestrant to see how well they work together.See study design
What are the potential side effects?
Possible side effects include typical reactions from chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. There may also be specific effects related to the new drug like liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial or gastric cancer has worsened after 2 treatments, including a platinum-based therapy.
Select...
My cancer has worsened despite standard treatments.
Select...
My breast cancer is HR+ HER2- and worsened after CDK4/6 inhibitor treatment.
Select...
My ovarian cancer is not responding to platinum-based treatments and has a specific genetic feature.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 43 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 43 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-222
[Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-222
[Phase 1] Rate and severity of adverse events
+2 moreSecondary outcome measures
[Phase 1 and Phase 2] Area under the concentration-time curve from time 0 to the time of the last measured concentration AUC(0-last)
[Phase 1 and Phase 2] Change in CA-125 levels
[Phase 1 and Phase 2] Clinical benefit rate (CBR)
+17 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: BLU-222 MonotherapyExperimental Treatment2 Interventions
Dose Escalation: Multiple doses for BLU-222 for oral administration Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation
Group II: BLU-222 + Ribociclib + FulvestrantExperimental Treatment3 Interventions
Dose Escalation: Multiple doses for BLU-222 for oral administration at doses deemed appropriate based on BLU-222 Monotherapy arm along with Ribociclib and Fulvestrant at the approved doses.
Dose Expansion: Oral dose of BLU-222 as determined during dose escalation and approved doses of Ribociclib and Fulvestrant
Group III: BLU-222 + FulvestrantExperimental Treatment2 Interventions
Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation + fulvestrant at the approved dose
Group IV: BLU-222 + CarboplatinExperimental Treatment2 Interventions
Dose Escalation: Multiple doses for BLU-222 for oral administration at doses deemed appropriate based on BLU-222 Monotherapy arm and multiple doses of Carboplatin at the approved dose.
Dose Expansion: Oral dose of BLU-222 as determined during Dose Escalation and Carboplatin IV infusion at approved dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Ribociclib
2018
Completed Phase 3
~2330
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
5,853 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endometrial or gastric cancer has worsened after 2 treatments, including a platinum-based therapy.I don't have lasting side effects from previous treatments.My cancer has worsened despite standard treatments.My breast cancer is HR+ HER2- and worsened after CDK4/6 inhibitor treatment.My ovarian cancer is not responding to platinum-based treatments and has a specific genetic feature.I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.I do not have any major surgeries planned within 2 weeks of starting the study drug.My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.I have a known bleeding disorder or brain hemorrhage.I have an active lung condition not caused by cancer within the last 28 days.I am not postmenopausal or surgically sterile and will not use or cannot use effective birth control.You have a history of heart rhythm issues or a family history of heart rhythm issues.I have been treated with specific cancer drugs before, except for a few allowed in early trial phases.I am willing and able to follow the study's schedule and procedures.I have had cancer other than in situ carcinomas that needed treatment within the last 2 years.My cancer has spread to my brain or spinal cord, causing worsening symptoms or needing more steroids.I do not have any active, uncontrolled infections like TB, hepatitis, AIDS, or COVID-19.I am not taking any medication or herbal remedy that can't be stopped 2 weeks before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: BLU-222 Monotherapy
- Group 2: BLU-222 + Carboplatin
- Group 3: BLU-222 + Ribociclib + Fulvestrant
- Group 4: BLU-222 + Fulvestrant
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.
How many healthcare facilities are presently conducting this trial?
"Subjects for this medical trial can be recruited from MD Anderson Cancer Center in Houston, Texas, Columbia University Herbert Irving Comprehensive Cancer Center in New york City and Florida Cancer Specialists in Sarasota, FL. Moreover, there are 5 other recruitment sites associated with the project."
Answered by AI
Are there any vacancies available for individuals to partake in this research?
"Affirmative. According to clinicaltrials.gov, this medical trial began recruiting patients on April 7th 2022 and was last updated November 21st of the same year. The study requires 366 participants from 5 different sites for enrollment."
Answered by AI
How many participants are permitted to enroll in this experiment?
"This medical trial necessitates a population of 366 individuals who meet the given criteria for participation. Patients have the option to join from two major sites, including MD Anderson Cancer Center in Houston and Columbia University Herbert Irving Comprehensive Cancer Centre in New york City."
Answered by AI
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