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PI3K Inhibitor

Elimusertib for Bone Metastasis

Phase 1
Waitlist Available
Led By Timothy A Yap
Research Sponsored by M.D. Anderson Cancer Center
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 up to 2 years
Awards & highlights

Summary

This trial is to find out the best dose of BAY1895344 and copanlisib to treat patients with advanced solid tumors. The two drugs may work together to stop the growth of tumor cells.

Eligible Conditions
  • Solid Tumors
  • Bone Metastasis
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response
Objective response rate (ORR)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (elimusertib, copanlisib)Experimental Treatment2 Interventions
Patients receive elimusertib PO BID on days 1-3 and 15-17, and copanlisib IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive elimusertib PO BID and copanlisib IV at the discretion of the treating physician.
Group II: Arm I (elimusertib, copanlisib)Experimental Treatment2 Interventions
Patients receive Patients receive elimusertib PO BID on days 1-3 and 15-17, and copanlisib IV over 1 hour on days 4 and 18. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive elimusertib PO BID and copanlisib IV at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,279 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
536 Total Patients Enrolled
Timothy A Yap, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
54 Total Patients Enrolled
~0 spots leftby Jul 2025
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