← Back to Search

PI3K inhibitor

Patients with Ewing sarcoma in Phase 2 for Ewing Sarcoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days.
Awards & highlights

Study Summary

This trial will test if a new drug is safe and helpful for kids with cancer that didn't respond to other treatments.

Eligible Conditions
  • Ewing Sarcoma
  • Neuroblastoma
  • Solid Tumors or Lymphoma in Children
  • Osteosarcoma
  • Rhabdomyosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and after the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants With Treatment-related Adverse Events (AEs).
Phase 1: Number of Subjects With Dose Limiting Toxicity (DLT)
Phase 1: Number of Subjects With Serious Adverse Events (SAEs)
+5 more
Secondary outcome measures
Phase 1: Area Under the Curve (AUC(0-168))
Phase 1: Copanlisib Maximum Drug Concentration (Cmax)
Phase 1: Objective Response Rate (ORR)
+6 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Patients with Rhabdomyosarcoma in Phase 2Experimental Treatment1 Intervention
RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.
Group II: Patients with Osteosarcoma in Phase 2Experimental Treatment1 Intervention
RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.
Group III: Patients with Neuroblastoma in Phase 2Experimental Treatment1 Intervention
Recommended Phase 2 dose (RP2D) for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.
Group IV: Patients with Ewing sarcoma in Phase 2Experimental Treatment1 Intervention
RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.
Group V: Dose escalation of BAY806946 in Phase 1Experimental Treatment1 Intervention
It is estimated that 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Safety and MTD/RP2D dose will be evaluated in 2 age groups (< 1 year old and ≥ 1 year old).

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,247 Previous Clinical Trials
25,333,554 Total Patients Enrolled
~4 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top