A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participa

• Status: Completed
• Trial end date: 2017-06-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this single-center, open-label, non-randomized study is to assess the excretion balance, pharmacokinetics, metabolism and absolute oral bioavailability of [14C]-labeled idasanutlin administered orally and [13C]-labeled idasanutlin administered intravenously in a single cohort of eligible participants. Participants will be screened for participation in this study within 21 days of receiving the first dose of study drug on Day

1. Treatment period will continue up to Day 28 after which participants will enter 28 day follow-up or the optional treatment extension of idasanutlin, depending on safety parameters and as per opinion of the Investigator.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, at the discretion of the Investigator

• Histologically or cytologically confirmed advanced malignancy, except leukemia and lymphoma

• Measureable or evaluable disease by Response evaluation criteria in solid tumors (RECIST) version 1.1, with no more than a single active malignancy in the previous 3 to 5 years prior to the administration of study drug

• Life expectancy of at least 12 weeks

• Participants taking opioid analgesics for pain should be on a stable pain and palliative care bowel regimen for one month prior to the first dose of study medication

• Adequate bone marrow, hepatic, and renal function

• Agreement to remain abstinent or use contraceptive methods specified in the study

Exclusion Criteria:

• History of any form of leukemia, except for Stage 0 - 1 chronic lymphocytic leukemia, not requiring treatment in addition to their underlying malignancy

• Have received hormonal therapy within the two weeks prior to the first dose of study drug

• Have pre-existing gastrointestinal disorders that may interfere with proper absorption of the drug

• History of seizure disorders or unstable Central Nervous System metastases (participants with stable CNS metastases allowed)

• Have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study

• Receive certain per protocol prohibited medications while on study. These medications must be discontinued 7 days prior to start of study drug

• Have bone marrow disorders, electrolyte imbalance, infrequent bowel movements (less than once per 48 hours), coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia

• Positive for human immunodeficiency virus currently receiving combination anti-retroviral therapy

• Regular work with ionizing radiation or radioactive material or treated with radiotherapy within 3 weeks prior to the first dose of study drug

• Refuse to potentially receive blood products and/or have a hypersensitivity to blood products