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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

Must not have

Have clinically significant, uncontrolled, cardiovascular disease including congestive heart failure Grade III or IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmia that may cause QT prolongation (eg, Type II second degree heart block or third-degree heart block)

Have planned major surgical procedure within 14 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My endometrial or gastric cancer has worsened after 2 treatments, including a platinum-based therapy.

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My cancer has worsened despite standard treatments.

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My breast cancer is HR+ HER2- and worsened after CDK4/6 inhibitor treatment.

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My ovarian cancer is not responding to platinum-based treatments and has a specific genetic feature.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart problems like recent heart attacks or uncontrolled high blood pressure.

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I do not have any major surgeries planned within 2 weeks of starting the study drug.

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I don't have lasting side effects from previous treatments.

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My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.

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I have a known bleeding disorder or brain hemorrhage.

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I am willing and able to follow the study's schedule and procedures.

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My cancer has spread to my brain or spinal cord, causing worsening symptoms or needing more steroids.

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I do not have any active, uncontrolled infections like TB, hepatitis, AIDS, or COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Fulvestrant

2011

Completed Phase 3

~3520

Carboplatin

2014

Completed Phase 3

~6120