Trials / Terminated
TerminatedNCT03458728
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Relapsed or Refractory Solid Tumors or Lymphoma in Children
- Neuroblastoma
- Osteosarcoma
- Rhabdomyosarcoma
- Ewing Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-04-30
- Primary completion
- 2023-02-01
- Completion
- 2023-02-01
- First posted
- 2018-03-08
- Last updated
- 2023-12-04
- Results posted
- 2023-12-04
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03458728. Inclusion in this directory is not an endorsement.