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Two Parts:

Part A: 14C-labeled OSI-906

Part B: (Optional) OSI-906 (non-labeled)

radio-labeled OSI-906

OSI-906

Medical Director

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.

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of 14C-OSI-906 in Subjects With Advanced Solid Tumors With an Optional Treatment Phase

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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)

Outcome Measure for Part A of OSI-906 distribution between cellular components and plasma

Astellas Pharma Global Development, Inc.

Antineoplastic Agents

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

E7080

Akihiko Tsuruoka

The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.

An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.

DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.

Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.

Eisai Inc.

All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses. Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.

E7080 Group

Age, Continuous

Male

Female

Sex/Gender, Customized

To Elucidate the Pharmacokinetic Profile of E7080

Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.

Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day

All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body	NCT01529684	Advanced Solid ... Pharmacokinetic...	radio-labeled O... OSI-906	18 Years -	Astellas Pharma Inc
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors	NCT00280397	Cancer: Solid T...	E7080	20 Years - 75 Years	Eisai Inc.
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors	NCT00280397	Cancer: Solid T...	E7080	20 Years - 75 Years	Eisai Inc.

Spots Global Cancer Trial Database for cancer, solid tumors