Safety and Preliminary Efficacy of Once-Weekly Split-Dose Selinexor in Soft Tissue Sarcoma: Results of the Phase Ib METSSAR Clinical Trial

Funding

METSSAR was an investigator-initiated trial at Princess Margaret Cancer Centre, University Health Network, Toronto, Canada. Partial funding as well as investigational product support was provided by Karyopharm Therapeutics.

Conflicts of Interest/Competing Interests

A. Salawu has received research funding from PTC Therapeutics; speaker fees from Medison pharma; and advisory board/consulting fees from Boehringer Ingelheim, Amgen, Bayer, Astellas, Taiho, and Knight Therapeutics. G. Watson has received travel grants from Bristol Meyer Squibb, Abbvie; Honoraria from Pfizer, Astra Zeneca, Knight Therapeutics, Novartis, Boehringer Ingelheim, Gilead and advisory board/consulting fees from Novartis and Boehringer Ingelheim. A.R. Abdul Razak has received research funding from Boehringer Ingelheim, Deciphera, Karyopharm Therapeutics, Pfizer, Roche/Genentech, Bristol-Myers Squibb, MedImmune, Amgen, GlaxoSmithKline, Blueprint Medicines, Merck, Abbvie, Adaptimmune, Iterion Therapeutics, 23&Me, Rain Therapeutics, Neoleukin Therapeutics, Daiichi Sankyo, Symphogen, Frontier Therapeutics; and advisory board/consulting fees from Adaptimmune, Bayer, Boehringer Ingelheim, GlaxoSmithKline, Medison, Inhibrx; and payment for expert testimony from Medison. E.R. Malone, E. Al-Ezzi, S. Genta, O. Vornicova, L. Wang, L. Arones, M. Phillips, J. Lee, and A.A. Gupta declare that they have no conflicts of interest that might be relevant to the contents of this article.

Ethics Approval and Informed Consent

The study protocol was approved by the Research Ethics Board (REB) at the Princess Margaret Cancer Centre, Toronto. All participants gave written informed consent, and the trial was performed in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines.

Consent to Publish

Not applicable.

Data Availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Code Availability

Not applicable.

Authors’ Contributions

Conception and design of study: A.R. Abdul Razak, E.R. Malone. Acquisition of data: A. Salawu, E. Al-Ezzi, S. Genta, O. Vornicova, L. Wang, L. Arones, M. Phillips, J. Lee, G. Watson, A.A. Gupta, A.R. Abdul Razak. Analysis and/or interpretation of data: A. Salawu, E.R. Malone, E. Al-Ezzi, S. Genta, O. Vornicova, L. Wang, L. Arones, M. Phillips, J. Lee, G. Watson, A.A. Gupta, A.R. Abdul Razak. Approval of the version of the manuscript to be published: A. Salawu, E.R. Malone, E. Al-Ezzi, S. Genta, O. Vornicova, L. Wang, L. Arones, M. Phillips, J. Lee, G. Watson, A.A. Gupta, A.R. Abdul Razak.

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