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

Status
Active
Cancer Type
Lymphoma
Neuroblastoma
Sarcoma
Trial Phase
Phase I
Phase II
Eligibility
6 Months - 21 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03458728
Protocol IDs
19176 (primary)
NCI-2018-00809
2017-000383-15
Study Sponsor
Bayer Corporation

Summary

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.

Eligibility

  1. 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
  2. Male or female patients from 6 months to = 21 years old at the time of study enrollment
  3. Confirmation of diagnosis:
  4. 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.
  5. 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.
  6. 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.
  7. Performance level: Lansky = 50% for patients = 16 years of age and Karnofsky = 50% for patients > 16 years of age.
  8. Adequate bone marrow, renal and liver function.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.