Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients



Status:Recruiting
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:April 30, 2018
End Date:August 24, 2021
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma

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 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.

- Patients with solid tumors must have measurable or evaluable (for neuroblastoma
and Ewing sarcoma) disease. 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.
We found this trial at
18
sites
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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Birmingham, AL
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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Aurora, Colorado 80045
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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