Status:
COMPLETED
A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03362723
Start Date
November 27 2017
End Date
June 11 2019
Last Update
June 19 2019
Active Locations (11)
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1
University of Colorado
Aurora, Colorado, United States, 80045-2517
2
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States, 06520
3
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, United States, 63110
4
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States, 89169