Spots Global Cancer Trial Database for A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
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Trial Identification
Brief Title: A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
Official Title: A Multi-Center, Open-Label, Clinical Pharmacology Study for Idasanutlin, an MDM2 Antagonist With a Hybrid Randomized/Sequential, Single-Dose, 4-Period, Crossover Design to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Patients With Solid Tumors
Study ID: NCT03362723
Conditions
Interventions
Study Description
Brief Summary: This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral administration of a 300 milligrams (mg) dose in participants with solid tumors for whom no further treatment options are available. Following the four administrations of idasanutlin in the BE/rBA cycle of the study (Cycle 1), participants who have no clinically defined progressive disease and who recover from any prior treatment toxicity to Grade less than or equal to (\</=) 1 may enter the optional treatment extension phase. This extension phase will continue for additional 28-day cycles or until disease progression or unacceptable toxicity is observed.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado, Aurora, Colorado, United States
Yale Cancer Center; Medical Oncology, New Haven, Connecticut, United States
Washington University; Wash Uni. Sch. Of Med, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley, Las Vegas, Nevada, United States
University of Oklahoma Health Sciences Center; Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
New Orleans Center for Clinical Research, Knoxville, Tennessee, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Jewish General Hospital / McGill University, Montreal, Quebec, Canada
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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