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)
NCT ID: NCT02828930
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2016-09-08
2017-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Idasanutlin
On Day 1, 300 milligram (mg) idasanutlin tablet orally and 100 mg \[14C\]-radiolabeled idasanutlin capsule orally (2, 50 mg capsules containing approximately 100 microcurie of radioactivity). After 5 hours and 45 minutes of the oral dose, 100 microgram (mcg) of \[13C\]-radiolabeled idasanutlin will be administered over a 15-minute intravenous (IV) infusion. On Day 11, idasanutlin matching placebo aqueous dispersion orally and approximately after 1 hour, 400 mg idasanutlin tablet will be administered orally in the form of an aqueous dispersion. On Day 19, 400 mg idasanutlin tablet will be administered orally in the form of an aqueous dispersion. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days, and no treatment during 23 days of 28-day cycle, until the development of progressive disease, unacceptable toxicity, consent withdrawal or any other criteria for removal.
Idasanutlin
Idasanutlin 300 mg tablet orally on Day 1; 400 mg tablet orally on Day 11 and Day 19. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days of 28-day cycle.
Placebo
Placebo matching to idasanutlin aqueous dispersion will be administered orally on Day 11.
[13C]-radiolabeled Idasanutlin
\[13C\]-radiolabeled idasanutlin 100 mcg will be administered as IV infusion over 15-minute on Day 1.
[14C]-radiolabeled Idasanutlin
\[14C\]-radiolabeled idasanutlin 100 mg capsule (2, 50 mg capsules containing approximately 100 microcurie of radioactivity) will be administered orally on Day 1.
Interventions
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Idasanutlin
Idasanutlin 300 mg tablet orally on Day 1; 400 mg tablet orally on Day 11 and Day 19. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days of 28-day cycle.
Placebo
Placebo matching to idasanutlin aqueous dispersion will be administered orally on Day 11.
[13C]-radiolabeled Idasanutlin
\[13C\]-radiolabeled idasanutlin 100 mcg will be administered as IV infusion over 15-minute on Day 1.
[14C]-radiolabeled Idasanutlin
\[14C\]-radiolabeled idasanutlin 100 mg capsule (2, 50 mg capsules containing approximately 100 microcurie of radioactivity) will be administered orally on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Countries
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Other Identifiers
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RG7388
Identifier Type: OTHER
Identifier Source: secondary_id
2015-002532-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP29910
Identifier Type: -
Identifier Source: org_study_id