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 Participants With Solid Tumors (Malignancies)

  • Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • Hungary
Trial Identifier:

NCT02828930 RG7388 NP29910

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02828930,NP29910,RG7388 Trial Identifier
      Idasanutlin, Placebo, [13C]-radiolabeled Idasanutlin, [14C]-radiolabeled Idasanutlin Treatments
      Solid Tumors Condition
      Official Title

      A Single-Center, Open-Label Study Investigating 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 Patients With Solid Tumors

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      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

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