Dataset Information

First-in-Human, Healthy Volunteers Integrated Protocol of ETC-206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug.

ABSTRACT: In the last decade, drug development has tackled substantial challenges to improve efficiency and facilitate access to innovative medicines. Integrated clinical protocols and the investigation of targeted oncology drugs in healthy volunteers (HVs) have emerged as modalities with an increase in scope and complexity of early clinical studies and first-in-human (FIH) studies in particular. However, limited work has been done to explore the impact of these two modalities, alone or in combination, on the scientific value and on the implementation of such articulated studies. We conducted an FIH study in HVs with an oncology targeted drug, an Mnk 1/2 small molecule inhibitor. In this article, we describe results, advantages, and limitations of an integrated clinical protocol with an oncology drug. We further discuss and indicate points to consider when designing and conducting similar scientifically and operationally demanding FIH studies.

SUBMITTER: Teneggi V

PROVIDER: S-EPMC6951458 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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First-in-Human, Healthy Volunteers Integrated Protocol of ETC-206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug.

Teneggi Vincenzo V Novotny-Diermayr Veronica V Lee Lay Hoon LH Yasin Maryam M Yeo Pauline P Ethirajulu Kantharaj K Gan Sylvia Bong Hwa SBH Blanchard Stephanie E SE Nellore Ranjani R Umrani Dhananjay N DN Gomeni Roberto R Teck Darren Lim Wan DLW Li Greg G Lu Qing Shu QS Cao Yang Y Matter Alex A

Clinical and translational science 20190909 1

In the last decade, drug development has tackled substantial challenges to improve efficiency and facilitate access to innovative medicines. Integrated clinical protocols and the investigation of targeted oncology drugs in healthy volunteers (HVs) have emerged as modalities with an increase in scope and complexity of early clinical studies and first-in-human (FIH) studies in particular. However, limited work has been done to explore the impact of these two modalities, alone or in combination, on ...[more]

PMID: 31343094

Dataset Information

First-in-Human, Healthy Volunteers Integrated Protocol of ETC-206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug.

Publications

First-in-Human, Healthy Volunteers Integrated Protocol of ETC-206, an Oral Mnk 1/2 Kinase Inhibitor Oncology Drug.

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