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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
2,242 Previous Clinical Trials
25,332,825 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals does this research aim to achieve?

"The primary outcome of this clinical trial, which will be evaluated over a Approximately 13 months time frame is to Number of participants with Serious Adverse Events (SAEs). Secondary outcomes include PFS in each indication except for osteosarcoma which is defined as Phase 2: PFS is defined as the time from first dose of study drug to disease progression according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1) for solid tumor patients (except osteosarcoma) and SIOPEN or Curie score for neuroblastoma patients with Iodine-123 metaiod"

Answered by AI

Are we still recruiting participants for this research project?

"Yes, as of 10/21/2022 this study detailed on clinicaltrials.gov is actively recruiting participants. This particular trial was first posted on 4/30/2018."

Answered by AI

How can I become a participant in this research project?

"This study is looking for 142 individuals that have malignant mixed tumors and meet the following age criteria: 6 months to 21 years old. It's crucial that potential patients also fit the Phase II requirements, which are having a histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma."

Answered by AI

Does this study have an age limit?

"This particular clinical study includes patients that fall within the age range of 6 months to 21 years old. There are a total of 2 different trials for people under 18 and 33 for those over 65."

Answered by AI

Do we have an accurate estimate of how many hospitals are conducting this trial at the moment?

"Children's Hospital of Los Angeles, St. Jude Children's Research Hospital, and Children's Hospital of Orange County are a few places where this clinical trial is enrolling patients. In total, there are 19 locations participating in the study."

Answered by AI

Have there been other similar trials in the past?

"BAY806946 has undergone clinical trials since 2012. The first one, which was sponsored by Bayer and took place in 2012 with 227 participants, resulted in the drug receiving Phase 2 approval. Now, there are 34 active trials for BAY806946 happening in 983 cities across 46 countries."

Answered by AI

Are there precedents for this kind of research being done with BAY806946?

"Right now, there are a total of 34 ongoing studies investigating BAY806946. This includes 3 Phase 3 clinical trials. The majority of these research projects are taking place in Houston, Texas; although, there are 2139 different locations running active trials for this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients
2018. "Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03458728.
~4 spots leftby May 2025
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