A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
