Effect of Panitumumab on the Pharmacokinetics of Irinotecan

Part of paid clinical trials in Billings, Montana.

Sponsor
Amgen
Study ID
NCT00563316
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — DRUG
    The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.
  • Irinotecan — DRUG
    The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.

Study Details

The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.

Key Dates

Start date
Mar 31, 2008
Status verified
Mar 2016
Primary completion
Mar 31, 2009
Completion
Jun 30, 2010

Study Design

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

Arms

  • Experimental: Panitumumab + Irinotecan
    Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Irinotecan [ Time Frame: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1). ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteBillingsMontana59107-
Research SiteBillingsMontana--
Research SiteChapel HillNorth Carolina27599-
Research SiteChapel HillNorth Carolina--
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania--
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee--

Find similar trials in Billings, MT

By research site
Research Site· Billings, MTResearch Site· Chapel Hill, NCResearch Site· Philadelphia, PAResearch Site· Nashville, TN

Related Studies