A Phase 1 interventional study of radio-labeled OSI-906 and OSI-906 in Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906, sponsored by Astellas Pharma Global Development, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Astellas Pharma Global Development, Inc. · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.
This study includes two parts: Part A
Subjects will be admitted to the clinical research unit on Day -1 and remain confined to the unit until post dosing discharge criteria are met up to a maximum of 10 days. On Day 1, subjects will receive a single oral dose of 14C-labeled OSI-906.
Part B (optional)
Once the subject has completed part A, the subject may elect to continue participation in Part B. Subjects will receive OSI-906 (non-radiolabeled) twice daily by mouth. Subjects will be seen for scheduled visits every 7 days for the first 36 days and then every 21 days.
Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The subject has adequate organ function defined by the following laboratory parameters:
Exclusion Criteria:
Two Parts: Part A: 14C-labeled OSI-906 Part B: (Optional) OSI-906 (non-labeled)
Drug: radio-labeled OSI-906 · Drug: OSI-906
Part A: oral solution of 14C-OSI-906
Part B: oral tablets OSI-906
Radioactivity in whole blood and plasma
Outcome measure for Part A: Area under the time concentration curve extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable time point (AUClast), Maximum Plasma Concentration (Cmax), Time to maximum concentration (Tmax), Terminal half-life (t 1/2), Apparent Body Clearance after dosing (CL/F), and Apparent volume of distribution (Vz/F)
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Radioactivity ratio in blood/plasma
Outcome Measure for Part A of OSI-906 distribution between cellular components and plasma
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Excretion ratio and cumulative excretion of radioactivity in urine and feces
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Composite of Pharmacokinetics of OSI-906 in plasma: AUC inf, AUC last, C max, t max, t 1/2, CL/F, and Vz/F
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Composite of Pharmacokinetics of OSI-906 in urine: Cumulative amount of drug excreted into urine, feces or bile up to collection time of last measurable concentration (Ae last), Renal Clearance (CL R), and percentage of dose excreted (Ae last%)
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Metabolic Profile: Profiling of possible metabolites in OSI-906 plasma, urine, and feces
Outcome measure for Part A
Time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906
Safety as assessed by recording adverse events, laboratory assessments and vital signs, and electrocardiograms (ECGs)
Outcome measures for Part A and Part B
Time frame: For Part A: Days 1-10 and/or 30 days post treatment visit. For Part B: Treatment Period 1 (TP1) through 30 day post treatment visit (up to two years)
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Global Development, Inc.