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

NCT ID: NCT01529684

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-19
• Study Completion Date: 2013-02-20

Brief Summary

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.

Detailed Description

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.

Conditions

Advanced Solid Tumors; Pharmacokinetics of 14C-OSI-906

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

OSI-906

Two Parts:

Part A: 14C-labeled OSI-906

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

Group Type: EXPERIMENTAL

radio-labeled OSI-906

Intervention Type: DRUG

Part A: oral solution of 14C-OSI-906

OSI-906

Intervention Type: DRUG

Part B: oral tablets OSI-906

Interventions

radio-labeled OSI-906

Part A: oral solution of 14C-OSI-906

Intervention Type: DRUG

OSI-906

Part B: oral tablets OSI-906

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The subject has histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or non-measurable disease) for which no conventional therapy is available
• The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
• The subject has a predicted life expectancy ≥12 weeks
• The subject has a fasting glucose ≤125 mg/dL (7 mmol/L) at Screening, Day -1 and pre-dose Day 1
• The subject has adequate organ function defined by the following laboratory parameters:

• absolute neutrophil count (ANC) ≥1.5 x 10 9/L
• platelet count ≥100 x 10 9/L
• total bilirubin ≤1.5 x upper limit of normal (ULN)
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if subject has documented liver metastases
• serum creatinine ≤1.5 x ULN
• potassium, calcium, and magnesium within normal limits or determined by the investigator to be not clinically significant (NCS)
• The subject has a negative cotinine test
• If male, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method while participating in the study and for 90 days after the last dose of study medication
• If female, the subject is surgically sterile or status post hysterectomy, post-menopausal, or is using 2 forms of medically acceptable methods of birth control, one of which must be a barrier method to prevent pregnancy and agrees to continue using this method from screening until 90 days after the last dose of study medication
• If female, the subject must not be breastfeeding at Screening, during the study period and for 90 days after last dose of study drug administration
• If female, the subject must not donate ova starting at Screening, and throughout the study period and for 90 days after last dose of study drug administration
• Female subject of child bearing potential has a negative pregnancy test at Screening and Day -1

Exclusion Criteria

• The subject has Type 1 or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
• The subject has a history of poorly controlled gastrointestinal disorder (s) that could affect the absorption or metabolism of study drug
• The subject has used IGF-1R inhibitor therapy in last 6 months
• The subject has hepatocellular carcinoma
• The subject has used a CYP1A2 inhibitor or inducer within 14 days prior to Day 1
• The subject has used drugs with a risk of causing QTc interval prolongation and Torsade de Pointes (TdP) within 14 days prior to Day 1
• The subject has a history (within last 6 months) of significant cardio-vascular disease
• The subject has a history (within the last 6 months) of significant arrhythmia disease, unless the disease is well-controlled with medication per the Principal Investigator's clinical judgment
• The subject has had major surgery ≤ 3 weeks prior to Day 1
• The subject has had radiation ≤ 3 weeks prior to Day 1
• The subject has had chemotherapy ≤ 3 weeks prior to Day 1
• The subject has participated in a radiolabeled study in the last 12 months
• The subject has a history of cerebrovascular accident (CVA) within 6 months prior to Day 1 or that resulted in ongoing neurologic instability
• The subject has an active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to Day 1) that would impair the ability of the subject to receive study drug
• The subject has participated in any interventional clinical study within 21 days or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening
• The subject has a history of any psychiatric condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent
• The subject is pregnant or lactating
• The subject has symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment, (i.e., anti-epileptic medication) within 28 days prior to Day 1
• The subject has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Comprehensive Clinical Development NW, Inc.

Tacoma, Washington, United States

Countries

United States

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=269

Link to results on the Astellas Clinical Study Results website

Other Identifiers

OSI-906-104

Identifier Type: -

Identifier Source: org_study_id