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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Pharmacokinetics of 14C-OSI-906

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Radioactivity in whole blood and plasma

Outcome Description:

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 Time Frame:

Up to 10 days from time of receipt of 14C-labeled OSI-906

Safety Issue:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

OSI-906-104

NCT ID:

NCT01529684

Start Date:

January 2012

Completion Date:

February 2013

Related Keywords:

  • Advanced Solid Tumors
  • Pharmacokinetics of 14C-OSI-906
  • Cancer, solid tumors
  • oncology patients
  • OSI-906
  • mass balance
  • Absorption, Metabolism, and Excretion of OSI-906
  • Metabolic profile of 906
  • Pharmacokinetics of 14C-OSI-906
  • Neoplasms

Name

Location

Northwest Medical Specialties, PLLCTacoma, Washington  98405
Comprehensive Clinical Development NW, Inc.Tacoma, Washington  98418