Gelderblom, Hans
Jones, Robin L.
George, Suzanne
Valverde Morales, Claudia
Benson, Charlotte
Jean-Yves Blay,
Renouf, Daniel J.
Doi, Toshihiko
Le Cesne, Axel
Leahy, Michael
Hertle, Sabine
Aimone, Paola
Brandt, Ulrike
Schӧffski, Patrick
Article History
Received: 4 September 2019
Accepted: 12 February 2020
First Online: 9 March 2020
Ethics approval and consent to participate
: The study was performed in accordance with the Declaration of Helsinki, and has been reviewed and approved by the independent ethics committee and/or local review board at each participating institution (details are provided in InternalRef removed). All participants provided written informed consent prior to the study. The study was registered at clinicaltrials.gov (NCT01468688).
: Not applicable.
: Novartis will not provide access to patient-level data, if there is a reasonable likelihood that individual patients could be re-identified. Phase 1 studies, by their nature, present a high risk of patient re-identification; therefore, patient individual results for Phase 1 studies cannot be shared. In addition, clinical data, in some cases, have been collected subject to contractual or consent provisions that prohibit transfer to third parties. Such restrictions may preclude granting access under these provisions. Where co-development agreements or other legal restrictions prevent companies from sharing particular data, companies will work with qualified requestors to provide summary information where possible.
: All the investigators received a research grant to conduct the trial discussed in the publication. In addition, H.G. reports grants to his institute. R.L.J. received honoraria and consultation fees from Adaptimmune, Blueprint, Clinigen, Eisai, Epizyme, Daichii Sankyo, Deciphera Pharmacuticals, Immunedesign, Johnson and Johnson, Eli Lilly, Merck, Pfizer and Pharmamar. S.G. reports being a consultant and on the advisory board of ARIAD, Pfizer, Bayer, Blueprint Medicines, Deciphera Pharmaceuticals, Exelixis, Eli Lilly, AstraZeneca, Research to Practice, MORE Health and Huron Consulting; reports receiving research funds to her institution from ARIAD, Pfizer, Bayer, Blueprint Medicines, Deciphera Pharmaceuticals and Novartis; royalties from Wolters Kluwer Health (ExternalRef removed); equity from AbbVie (none currently), Abbott Labs and Allergan; reports holding leadership positions as Vice-Chair Alliance for Clinical Trials in Oncology and Vice-President of Alliance Foundation. CVM reports receiving fees for the advisory board from Novartis, Pfizer and Bayer. J.Y.B. reports receiving grant, personal fees and nonfinancial support from Novartis. D.J.R., M.L. and P.S. received institutional funding from Novartis for clinical and translational research in GIST and other sarcomas. T.D. reports research grant and personal fees from Lilly, Chugai Pharma, Kyowa Hakko Kirin, MSD, Daichi Sankyo, Sumitomo Group and Taiho, research grant from Novartis, Merck Serono, Astellas Pharma, Janssen, Boehringer Ingelheim, Takeda, Pfizer, Celgene, Bristol Myers Squibb, AbbVie and Quintiles and personal fees from Amgen outside the submitted work. A.L.C. reports receiving personal fees from Pfizer, Pharmamar, Novartis, Amgen and Lilly. C.B. has no conflicts to disclose. S.H., P.A. and U.B. are employees of Novartis Pharma AG, Basel, Switzerland.
: The study was funded by Novartis Pharma AG, Basel, Switzerland.