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Phase 0 Key Points . Are Phase 0 studies feasible? Phase 0 recruitment is feasible but depends on patient altruism and prior physician-patient relationship. Statistical methodology is more challenging in Phase 0 trials, which involve novel PD endpoints and small number of samples.

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phase 0 key points
Phase 0 Key Points
  • Are Phase 0 studies feasible?
    • Phase 0 recruitment is feasible but depends on patient altruism and prior physician-patient relationship.
    • Statistical methodology is more challenging in Phase 0 trials, which involve novel PD endpoints and small number of samples.
    • Require additional up-front investment in imaging or assay development, in addition to that needed for standard PK.
phase 0 key points3
Phase 0 Key Points
  • In what circumstances are Phase 0 studies applicable for early drug development?
    • Phase 0 trials provide the opportunity to develop PD assays measuring target function in tumors in humans
      • Allows for the assessment of target inhibition as a potential primary endpoint in subsequent trials
      • Develop assay procedures—from tissue acquisition to the assay itself—that actually work in patients in the clinic
phase 0 key points4
Phase 0 Key Points
  • Does conducting a Phase 0 study save clinical development time?
    • Critical question is time—will take years to assess
    • Likely that imaging-driven PD will make a major impact soon
phase 0 key points5
Phase 0 Key Points
  • Do you know whom to ask for help?
special thanks to the nci phase 0 team
DCTD

James H. Doroshow

Joseph E. Tomaszewski

Jerry Collins

Tony Murgo

(Jennifer Low)

(Oxana Pickeral)

Melinda Hollingshead

Gurmeet Kaur

Sherry Yang

Larry Phillips

Larry Rubinstein

Seth Steinberg

Alice Chen

CCR

Shivaani Kummar

Martin Gutierrez

Richard Chang

Anthony Kim

Yvonne Horneffer

Lamin Juwara

Maryann Yancey

Janelle Bingham

Yves Pommier

William M. Bonner

Olga A. Sedelnikova

Christophe Redon

Special Thanks to the NCI Phase 0 Team
  • Abbott Laboratories ABT-888 Team
special thanks to the nci phase 0 team7
SAIC

Anne Monks

Will Jacob

Carrie Bonomi

Suzanne Borgel

John Carter

Raymond Divelbiss

Kelly Dougherty

Christina Hernandez

Les Stotler

Sadie Frary

Jagada Thillianathan

Jessica Zalek

Kimberly Hill

Eva Majerova

Gina Uhlenbrauck

FDA

Ray Klecker

SAIC

Ralph Parchment

Robert Kinders

Jay Ji

Sonny Khin

Weimin Zhu

Yiping Zhang

Kate Luyegu

Sylvan McDowell

Ravithat Putvatana

Tiziano DiPaolo

Sima Hayavi

Kristi Robillard

Dorj Dorjsuren

Shawn Clopper

Will Yutzy

Dwight Simmons

Melanie Simpson

Vali Sevastita

Special Thanks to the NCI Phase 0 Team
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