Trial Condition(s):

Mixed Tumor, Malignant

Safety, tolerability, efficacy and pharmacokinetics of copanlisib in pediatric patients

Bayer Identifier:

19176

ClinicalTrials.gov Identifier:

NCT03458728

EudraCT Number:

2017-000383-15

Recruiting

Trial Purpose

This study is designed to investigate whether the use of copanlisib is safe, feasible and
beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.

Inclusion Criteria
-Signed informed consent form by patients and/or patients’ parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
-Male or female patients from 6 months to ≤ 21 years old at the time of study enrollment
-Confirmation of diagnosis:
--Phase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis, with measurable or evaluable disease, for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ≥ 1 prior line of therapy.
--Phase II: patients must have 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.
--In Phase II, patients with solid tumors must have measurable disease (evaluable disease is acceptable for neuroblastoma and Ewing sarcoma). Tumor assessment will be done via computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography-computed
tomography (PET-CT). Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion. Bone scans (if clinically indicated) should be obtained within ≤ 4 weeks prior to the start of treatment.
-Performance level: Lansky ≥ 50% for patients ≤ 16 years of age and Karnofsky ≥ 50% for patients > 16 years of age.
-Adequate bone marrow, renal and liver function.
Exclusion Criteria
-Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ≥ 2).
-History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
-Diabetes mellitus.
-Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
-Patients with central nervous system (CNS) malignancies.

Trial Summary

Enrollment Goal
142
Trial Dates
black-arrow
Phase
1/2
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

The Children's Hospital

Aurora, United States, 80045

Status
Recruiting
 
Locations

Children's Hospital of Philadelphia

Philadelphia, United States, 19104

Status
Recruiting
 
Locations

St. Jude Children's Research Hospital

Memphis, United States, 38105

Status
Recruiting
 
Locations

Cincinnati Children's Hospital and Medical Center

Cincinnati, United States, 45229

Status
Recruiting
 
Locations

Dana-Farber Cancer Institute

Boston, United States, 02215

Status
Recruiting
 
Locations

Columbia University Medical Center

New York, United States, 10032

Status
Recruiting
 
Locations

Children's Hospital of Alabama

Birmingham, United States, 35233

Status
Recruiting
 
Locations

Children's Healthcare of Atlanta

Atlanta, United States, 30322

Status
Recruiting
 
Locations

Riley Hospital For Children

Indianapolis, United States, 46202

Status
Recruiting
 
Locations

Seattle Children's Hospital

Seattle, United States, 98105

Status
Recruiting
 
Locations

Children's Hospital of Orange County

Orange, United States, 92868-3974

Status
Recruiting
 
Locations

Children's National Medical Center

Washington, United States, 20010-2970

Status
Recruiting
 
Locations

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, United States, 15224

Status
Recruiting
 
Locations

Texas Children's Hospital

Houston, United States, 77030

Status
Recruiting
 
Locations

C.S. Mott Children's Hospital

Ann Arbor, United States, 48109

Status
Recruiting
 
Locations

Children's Hospital of Los Angeles

Los Angeles, United States, 90027-6089

Status
Recruiting
 
Locations

Memorial Sloan-Kettering Cancer Center

New York, United States, 10065

Status
Recruiting
 
Locations

University of Texas Southwestern Medical Center

Dallas, United States, 75390

Status
Recruiting
 
Locations

Cook Children's Medical Center

Fort Worth, United States, 76104-2796

Status
Recruiting
 

Trial Design