NCT03458728 - Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2018

Primary Completion Date

February 1, 2023

Study Completion Date

February 1, 2023

Conditions

Relapsed or Refractory Solid Tumors or Lymphoma in ChildrenNeuroblastomaOsteosarcomaRhabdomyosarcomaEwing Sarcoma

Interventions

DRUG

Copanlisib (BAY806946)

Copanlisib will be dosed on Day 1, Day 8, and Day 15 of every 28-day cycle. Phase 1: 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Phase 2: RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.

Trial Locations (14)

10032

Columbia University Medical Center, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

30322

Children's Healthcare of Atlanta, Atlanta

35233

Children's Hospital of Alabama, Birmingham

38105

St. Jude Children's Research Hospital, Memphis

45229

Cincinnati Children's Hospital and Medical Center, Cincinnati

46202

Riley Hospital For Children, Indianapolis

77030

Texas Children's Hospital, Houston

80045

The Children's Hospital, Aurora

98105

Seattle Children's Hospital, Seattle

92868-3974

Children's Hospital of Orange County, Orange

20010-2970

Children's National Medical Center, Washington D.C.

02215

Dana-Farber Cancer Institute, Boston