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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID: NCT03362723
Run by: Hoffmann-La Roche
People needed: 48
Starts: 2017-11-27
Expected to finish: 2019-06-11
Last updated by the study team: 2019-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant must have histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the participant
Measureable or evaluable disease by RECIST v1.1 for solid tumors prior to the administration of study drug
Ability to understand and willingness to sign a written informed consent form and comply with all study requirements
Life expectancy of greater than or equal to (>/=)12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
New York Heart Association (NYHA) status of less than or equal to (</=)1
Women of childbearing potential and men should remain abstinent or agree to use an effective form of contraception and to continue its use for the duration of study treatment and for a period of time after the last dose of study treatment
Adequate bone marrow function, hepatic function, and renal function

You may not qualify if…

Participants with prostate cancer who are unable to interrupt treatment with ketoconazole; ketoconazole treatment must be discontinued 2 weeks prior to first dose of study medication and is not allowed during Cycle 1, but may be used in the optional extension phase.
Administration of investigational agents or investigational drugs </=4 weeks or less than (<)5 times the terminal half-life prior to study treatment start, whichever is longer
Active gastrointestinal (GI) conditions and uncontrolled irritable bowel disease or pre-existing GI disorders that may interfere with proper absorption of the study drug
History of allergic reactions attributed to components of the formulated product
History of seizure disorders or unstable central nervous system metastases
Presence of any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Evidence of electrolyte imbalance
Pregnant or breast feeding
Known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
Current treatment with oral or parenteral anti-coagulants/antiplatelet agents
Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy that has not resolved to Grade </=2, except alopecia
Last dose of prior anti-tumor therapy <21 days prior to the first administration of idasanutlin or <5 times terminal half-life of that therapy, whichever is shorter
Refusal to potentially receive blood products and/or have a hypersensitivity to blood products
Known bone marrow disorders which may interfere with bone marrow recovery or participants with delayed recovery from prior chemoradiotherapy
Planned procedure or surgery during the study
History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Blood transfusion within 4 weeks prior to screening
History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Current treatment with medications that are well known to prolong the QT interval

Where it is running

University of Colorado — Aurora, Colorado, United States
Yale Cancer Center; Medical Oncology — New Haven, Connecticut, United States
Washington University; Wash Uni. Sch. Of Med — St 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.