OSI-906 and Irinotecan in Patients With Advanced Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT01016860
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OSI-906 — DRUG
    OSI-906 will be given orally in tablets for one dose starting on Cycle 1 Day-3 then on Cycle 1 Day 2-4, 8-10 and 15-17. Cycle is 21 days. Subsequent cycles, dosing will start be Day 1-3, 8-10 and 15-17
  • irinotecan — DRUG
    Irinotecan will be administered IV over 90 minutes on Day 1 and 8 of a 21-day cycle

Study Details

This study plans to learn more about an investigational drug called OSI-906. OSI-906 is being looked at to see if it could be a treatment for advanced cancer. "The FDA is the U.S. government agency that reviews the results of research of drugs and decides if it can be sold in the U.S. OSI-906 has been given to over 185 people with cancer.

Key Dates

Start date
Dec 31, 2009
Status verified
Oct 2013
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OSI-906 and/or irinotecan
    Dose Escalation Phase: Treatment for Cycle 1 will commence on Day -3 of a 21-day cycle (3 weeks) when a single dose OSI-906 is given with full pharmacokinetics(PK) sampling at predetermined time points. Irinotecan will be administered intravenously over 90 minutes on Day 1 and Day 8 with full PK sampling on Day 1. The institution of oral dosing of OSI-906 2-4, 8-10, 15-17 (for cycle 1 only) will be given followed by full PK sampling of both drugs on Day 8. Pre-dose samples of OSI-906 will be drawn on Cycle 1 Days 8, 10, 15, 17 and Cycle 2 Days 1, 8, 10, 15 and 17. For Cycle 2 and thereafter, both drugs will be administered starting on Day 1.

Primary Outcome Measure

Maximum tolerated dose (MTD) and the recommend phase II dose (RP2D) for the combination of irinotecan and OSI-906 in patients with advanced cancer. [ Time Frame: Up to 28 days of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
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By specialty
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By research site
University of Colorado Denver· Aurora, CO

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