drugset / Trial / NCT00939770
Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
Phase 1/2
Completed
122 enrolled
Children's Oncology Group
National Cancer Institute (NCI) · collabPfizer · collab
SequentialOpen-labelTreatment
Summary
This phase 1/2 trial the studies side effects and best dose of crizotinib and to see how well it works in treating young patients with solid tumors or anaplastic large cell lymphoma that has returned after a period of improvement or does not respond to treatment. Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. (Phase 1 completed 2/15/13)
Timeline
- Start
- 2009-09-21
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
Publications
- Bartlett JA, Culver N, Santangelo M, Prpich A, Long E, Sagawa K, Shanker R, Xu H, Wilner K. Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. Pharmaceut Med. 2026 May;40(3):193-207. doi: 10.1007/s40290-026-00604-2. Epub 2026 Apr 1.
- Foster JH, Voss SD, Hall DC, Minard CG, Balis FM, Wilner K, Berg SL, Fox E, Adamson PC, Blaney SM, Weigel BJ, Mosse YP. Activity of Crizotinib in Patients with ALK-Aberrant Relapsed/Refractory Neuroblastoma: A Children's Oncology Group Study (ADVL0912). Clin Cancer Res. 2021 Jul 1;27(13):3543-3548. doi: 10.1158/1078-0432.CCR-20-4224. Epub 2021 Feb 10.
- Balis FM, Thompson PA, Mosse YP, Blaney SM, Minard CG, Weigel BJ, Fox E. First-dose and steady-state pharmacokinetics of orally administered crizotinib in children with solid tumors: a report on ADVL0912 from the Children's Oncology Group Phase 1/Pilot Consortium. Cancer Chemother Pharmacol. 2017 Jan;79(1):181-187. doi: 10.1007/s00280-016-3220-6. Epub 2016 Dec 28.
- Mosse YP, Lim MS, Voss SD, Wilner K, Ruffner K, Laliberte J, Rolland D, Balis FM, Maris JM, Weigel BJ, Ingle AM, Ahern C, Adamson PC, Blaney SM. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's Oncology Group phase 1 consortium study. Lancet Oncol. 2013 May;14(6):472-80. doi: 10.1016/S1470-2045(13)70095-0. Epub 2013 Apr 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crizotinib | Small molecule | 100 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 130 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 165 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 215 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 280 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 365 mg/m2 | Oral |