Wu, Jen-Hao
Pennesi, Edoardo
Bautista, Francisco
Garrett, May
Fukuhara, Kei
Brivio, Erica
Ammerlaan, Anneke C. J.
Locatelli, Franco
van der Sluis, Inge M.
Rossig, Claudia
Chen-Santel, Christiane
Bielorai, Bella
Petit, Arnaud
Starý, Jan
Díaz-de-Heredia, Cristina
Rives, Susana
O’Marcaigh, Aengus
Rizzari, Carmelo
Engstler, Gernot
Nysom, Karsten
Rubio-San-Simón, Alba
Bruno, Benedicte
Bertrand, Yves
Brethon, Benoît
Rialland, Fanny
Plat, Geneviève
Dirksen, Uta
Sramkova, Lucie
Zwaan, C. Michel http://orcid.org/0000-0001-6892-8268
Huitema, Alwin D. R.
Funding for this research was provided by:
Pfizer
Article History
Accepted: 19 May 2024
First Online: 22 June 2024
Declarations
:
: ITCC-059 was sponsored by Erasmus MC and financed by Pfizer.
: Susana Rives reports honoraria and/or travel support from Novartis, Servier, Celgene/Bristol Myers Squibb, Kite/ Gilead, Pfizer, and Amgen. Susana Rives reports being part of a Date and Safety Monitoring Board (DMSB) in a clinical trial sponsored by Novartis and of a data monitoring committee in a clinical trial sponsored by Autolus. Alwin D.R. Huitema is an Editorial Board member of <i>Clinical Pharmacokinetics</i>. Alwin D.R. Huitema was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Francisco Bautista is a member of a data monitoring committee for a clinical trial sponsored by Sanofi, had a consultant or advisory role for Bayer, Amgen, Roche Genentech, and EusaPharma and received honoraria for speaking at symposia from Roche Genentech. Claudia Rossig has received honoraria from BMS, Amgen, Novartis, Pfizer, and Roche Genentech. Franco Locatelli has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen, Miltenyi, Jazz Pharmaceutical, Medac, Neovii, Novartis, Sanofi, Sobi, Vertex, and Gilead. Alba Rubio-San-Simón had a consulting role for Eusa Pharma, Sanofi, and SERB, and has received honoraria from Eusa Pharma and Roche for educational events and travel expenses. Gernot Engstler has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Servier. C. Michel Zwaan reports serving as a consultant/advisory board member for Incyte, Takeda, Johnson&Johnson, Sanofi, Syndax, Bristol Meyers Squibb, Roche, Kura Oncology Inc., Novartis, Pfizer, AbbVie, Daiichi Sankyo, Servier, and Astra Zeneca, and has received institutional funding from Pfizer, Daiichi Sankyo, Takeda, AbbVie, Jazz Pharma, and Kura Oncology. May Garrett is an employee of and owns stock in Pfizer Inc. Kei Fukuhara is an employee of Pfizer Japan Inc. and owns stock in Pfizer Inc. Jen-Hao Wu, Edoardo Pennesi, Francisco Bautista, Erica Brivio, Anneke C.J. Ammerlaan, Inge M. van der Sluis, C. Michel Zwaan, and Alwin D.R. Huitema report institutional funding from Pfizer for this study.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
: Written informed consent was obtained from each participant before conducting any study procedures.
: Consent was obtained from participants in this trial.
: Anonymized data are available in consultation with the sponsor and subject to review.
: Not applicable.
: Study conception and design: CMZ and Pfizer Inc. through the development of the Pediatric Investigational Plan and its approval by the Paediatric Committee (PDCO) of the European Medicines Agency. Data collection and patient management: CMZ, ACJA, EP, EB, SR, FL, IMVDS, CR, CCS, BB, AP, JS, CDH, AO, CR, GE, KN, ARSS, BB, YB, BB, FR, GP, UD, LS. Data analysis and interpretation: CMZ, ADRH, JW, EB, EP, FB, MG, KF. Manuscript writing: all authors critically made a substantial contribution in writing the paper, reviewed the manuscript, and approved the final version for submission.