Safety, tolerability and pharmacokinetics of crizotinib in combination with cytotoxic chemotherapy for pediatric patients with refractory solid tumors or anaplastic large cell lymphoma (ALCL): a Children’s Oncology Group phase 1 consortium study (ADVL1212)
Purpose This phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic chemotherapy for children with refractory solid tumors and ALCL. Methods Pediatric patients with treatment refractory solid tumors or ALCL were eligi...
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Published in | Cancer chemotherapy and pharmacology Vol. 86; no. 6; pp. 829 - 840 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.12.2020
Springer Nature B.V |
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Abstract | Purpose
This phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic chemotherapy for children with refractory solid tumors and ALCL.
Methods
Pediatric patients with treatment refractory solid tumors or ALCL were eligible. Using a 3 + 3 design, crizotinib was escalated in three dose levels: 165, 215, or 280 mg/m
2
/dose BID. In Part A, patients received crizotinib oral solution (OS) in combination with topotecan and cyclophosphamide (topo/cyclo); in Part B, crizotinib OS was administered with vincristine and doxorubicin (vcr/dox). In Parts C and D, patients received topo/cyclo in combination with either crizotinib-formulated capsules (FC) or microspheres (cMS), respectively. Crizotinib pharmacokinetic evaluation was required.
Results
Forty-four eligible patients were enrolled, 39 were evaluable for toxicity. Parts A and B were terminated due to concerns regarding palatability and tolerability of the OS. In Part C, crizotinib, FC 215 mg/m
2
/dose BID, in combination with topo/cyclo was tolerated. In Part D, the maximum tolerated dose (MTD) was exceeded at 165 mg/m
2
/dose of crizotinib cMS. Pharmacokinetics of crizotinib in combination with chemotherapy was similar to single-agent crizotinib and exposures were not formulation dependent.
Conclusions
The RP2D of crizotinib FCs in combination with cyclophosphamide and topotecan was 215 mg/m
2
/dose BID. The oral solution of crizotinib was not palatable in this patient population. Crizotinib cMS was palatable; however, patients experienced increased toxicity that was not explained by the relative bioavailability or exposure and warrants further investigation.
Clinical trial registry
The trial is registered as NCT01606878 at Clinicaltrials.gov. |
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AbstractList | PurposeThis phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic chemotherapy for children with refractory solid tumors and ALCL.MethodsPediatric patients with treatment refractory solid tumors or ALCL were eligible. Using a 3 + 3 design, crizotinib was escalated in three dose levels: 165, 215, or 280 mg/m2/dose BID. In Part A, patients received crizotinib oral solution (OS) in combination with topotecan and cyclophosphamide (topo/cyclo); in Part B, crizotinib OS was administered with vincristine and doxorubicin (vcr/dox). In Parts C and D, patients received topo/cyclo in combination with either crizotinib-formulated capsules (FC) or microspheres (cMS), respectively. Crizotinib pharmacokinetic evaluation was required.ResultsForty-four eligible patients were enrolled, 39 were evaluable for toxicity. Parts A and B were terminated due to concerns regarding palatability and tolerability of the OS. In Part C, crizotinib, FC 215 mg/m2/dose BID, in combination with topo/cyclo was tolerated. In Part D, the maximum tolerated dose (MTD) was exceeded at 165 mg/m2/dose of crizotinib cMS. Pharmacokinetics of crizotinib in combination with chemotherapy was similar to single-agent crizotinib and exposures were not formulation dependent.ConclusionsThe RP2D of crizotinib FCs in combination with cyclophosphamide and topotecan was 215 mg/m2/dose BID. The oral solution of crizotinib was not palatable in this patient population. Crizotinib cMS was palatable; however, patients experienced increased toxicity that was not explained by the relative bioavailability or exposure and warrants further investigation.Clinical trial registryThe trial is registered as NCT01606878 at Clinicaltrials.gov. Purpose This phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic chemotherapy for children with refractory solid tumors and ALCL. Methods Pediatric patients with treatment refractory solid tumors or ALCL were eligible. Using a 3 + 3 design, crizotinib was escalated in three dose levels: 165, 215, or 280 mg/m 2 /dose BID. In Part A, patients received crizotinib oral solution (OS) in combination with topotecan and cyclophosphamide (topo/cyclo); in Part B, crizotinib OS was administered with vincristine and doxorubicin (vcr/dox). In Parts C and D, patients received topo/cyclo in combination with either crizotinib-formulated capsules (FC) or microspheres (cMS), respectively. Crizotinib pharmacokinetic evaluation was required. Results Forty-four eligible patients were enrolled, 39 were evaluable for toxicity. Parts A and B were terminated due to concerns regarding palatability and tolerability of the OS. In Part C, crizotinib, FC 215 mg/m 2 /dose BID, in combination with topo/cyclo was tolerated. In Part D, the maximum tolerated dose (MTD) was exceeded at 165 mg/m 2 /dose of crizotinib cMS. Pharmacokinetics of crizotinib in combination with chemotherapy was similar to single-agent crizotinib and exposures were not formulation dependent. Conclusions The RP2D of crizotinib FCs in combination with cyclophosphamide and topotecan was 215 mg/m 2 /dose BID. The oral solution of crizotinib was not palatable in this patient population. Crizotinib cMS was palatable; however, patients experienced increased toxicity that was not explained by the relative bioavailability or exposure and warrants further investigation. Clinical trial registry The trial is registered as NCT01606878 at Clinicaltrials.gov. This phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic chemotherapy for children with refractory solid tumors and ALCL. Pediatric patients with treatment refractory solid tumors or ALCL were eligible. Using a 3 + 3 design, crizotinib was escalated in three dose levels: 165, 215, or 280 mg/m /dose BID. In Part A, patients received crizotinib oral solution (OS) in combination with topotecan and cyclophosphamide (topo/cyclo); in Part B, crizotinib OS was administered with vincristine and doxorubicin (vcr/dox). In Parts C and D, patients received topo/cyclo in combination with either crizotinib-formulated capsules (FC) or microspheres (cMS), respectively. Crizotinib pharmacokinetic evaluation was required. Forty-four eligible patients were enrolled, 39 were evaluable for toxicity. Parts A and B were terminated due to concerns regarding palatability and tolerability of the OS. In Part C, crizotinib, FC 215 mg/m /dose BID, in combination with topo/cyclo was tolerated. In Part D, the maximum tolerated dose (MTD) was exceeded at 165 mg/m /dose of crizotinib cMS. Pharmacokinetics of crizotinib in combination with chemotherapy was similar to single-agent crizotinib and exposures were not formulation dependent. The RP2D of crizotinib FCs in combination with cyclophosphamide and topotecan was 215 mg/m /dose BID. The oral solution of crizotinib was not palatable in this patient population. Crizotinib cMS was palatable; however, patients experienced increased toxicity that was not explained by the relative bioavailability or exposure and warrants further investigation. The trial is registered as NCT01606878 at Clinicaltrials.gov. |
Author | Liu, Xiaowei Balis, Frank Weigel, Brenda J. Minard, Charles G. Voss, Stephan Fox, Elizabeth Mosse, Yael P. Adamson, Peter C. Blaney, Susan M. Greengard, Emily Reid, Joel M. Wilner, Keith |
AuthorAffiliation | 2. The Children’s Hospital of Philadelphia, Philadelphia, PA 3. Children’s Oncology Group, Monrovia, CA 7. Pfizer, Inc 4. Baylor College of Medicine, Houston, TX 1. University of Minnesota Masonic Cancer Center, Minneapolis, MN 6. Dana Farber Cancer Institute, Boston, MA 5. Mayo Clinic, Rochester, MN |
AuthorAffiliation_xml | – name: 1. University of Minnesota Masonic Cancer Center, Minneapolis, MN – name: 6. Dana Farber Cancer Institute, Boston, MA – name: 3. Children’s Oncology Group, Monrovia, CA – name: 5. Mayo Clinic, Rochester, MN – name: 2. The Children’s Hospital of Philadelphia, Philadelphia, PA – name: 4. Baylor College of Medicine, Houston, TX – name: 7. Pfizer, Inc |
Author_xml | – sequence: 1 givenname: Emily orcidid: 0000-0002-2963-5638 surname: Greengard fullname: Greengard, Emily email: emilyg@umn.edu organization: Masonic Cancer Center, University of Minnesota – sequence: 2 givenname: Yael P. surname: Mosse fullname: Mosse, Yael P. organization: St Jude Children’s Research Hospital – sequence: 3 givenname: Xiaowei surname: Liu fullname: Liu, Xiaowei organization: Children’s Oncology Group – sequence: 4 givenname: Charles G. surname: Minard fullname: Minard, Charles G. organization: Baylor College of Medicine – sequence: 5 givenname: Joel M. surname: Reid fullname: Reid, Joel M. organization: Mayo Clinic – sequence: 6 givenname: Stephan surname: Voss fullname: Voss, Stephan organization: Dana Farber Cancer Institute – sequence: 7 givenname: Keith surname: Wilner fullname: Wilner, Keith organization: Pfizer, Inc – sequence: 8 givenname: Elizabeth surname: Fox fullname: Fox, Elizabeth organization: St Jude Children’s Research Hospital – sequence: 9 givenname: Frank surname: Balis fullname: Balis, Frank organization: St Jude Children’s Research Hospital – sequence: 10 givenname: Susan M. surname: Blaney fullname: Blaney, Susan M. organization: Baylor College of Medicine – sequence: 11 givenname: Peter C. surname: Adamson fullname: Adamson, Peter C. organization: St Jude Children’s Research Hospital – sequence: 12 givenname: Brenda J. surname: Weigel fullname: Weigel, Brenda J. organization: Masonic Cancer Center, University of Minnesota |
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Keywords | Crizotinib Oncology Phase 1 Pediatric Chemotherapy combinations |
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Notes | AUTHOR CONTRIBUTIONS All authors have contributed to the manuscript in significant ways, have reviewed and agreed upon the manuscript content. Some authors have contributed to study design, whereas all have contributed to data interpretation, writing and critical revision of the manuscript. |
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This phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic... This phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic chemotherapy for... PurposeThis phase 1 study aimed to determine the safety, tolerability and recommended phase 2 dose (RP2D) of crizotinib in combination with cytotoxic... |
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SubjectTerms | Anaplastic large-cell lymphoma Bioavailability Cancer Research Chemotherapy Children Clinical Trial Report Consortia Cyclophosphamide Cytotoxicity Doxorubicin Exposure Lymphoma Medicine Medicine & Public Health Microspheres Oncology Palatability Patients Pediatrics Pharmacokinetics Pharmacology Pharmacology/Toxicology Solid tumors Targeted cancer therapy Topotecan Toxicity Tumors Vincristine |
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Title | Safety, tolerability and pharmacokinetics of crizotinib in combination with cytotoxic chemotherapy for pediatric patients with refractory solid tumors or anaplastic large cell lymphoma (ALCL): a Children’s Oncology Group phase 1 consortium study (ADVL1212) |
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