NCT03362723View on ClinicalTrials.gov

A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

June 11, 2019

Study Completion Date

June 11, 2019

Conditions
Solid Tumors
Interventions
DRUG

Idasanutlin

Participants will receive one 300-mg dose of each of the four different oral tablet formulations of idasanutlin (tablet A \[reference\], B, C, D) during Cycle 1, in the order specified for their assigned treatment arm (Treatment Sequence 1-4). Participants who enter the optional treatment extension phase will receive the reference tablet formulation of idasanutlin, as specified in the Optional Treatment Extension Arm description.

Trial Locations (11)

23502

Virginia Oncology Associates, Norfolk

37920

New Orleans Center for Clinical Research, Knoxville

63110

Washington University; Wash Uni. Sch. Of Med, St Louis

73104

University of Oklahoma Health Sciences Center; Stephenson Cancer Center, Oklahoma City

75230

Mary Crowley Medical Research Center, Dallas

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

89169

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley, Las Vegas

80045-2517

University of Colorado, Aurora

06520

Yale Cancer Center; Medical Oncology, New Haven

M5G 1Z5

Princess Margaret Cancer Center, Toronto

H3T 1E2

Jewish General Hospital / McGill University, Montreal

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03362723 - A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors | Biotech Hunter | Biotech Hunter