Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab

Sponsor
NantBioScience, Inc.
Study ID
NCT00891930
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Panitumumab — BIOLOGICAL
    Panitumumab 6 mg/kg administered via IV infusion over 60 minutes
  • Ganitumab — BIOLOGICAL
    AMG 479 12 mg/kg adminstered by IV infusion over 60 minutes
  • Irinotecan — DRUG
    Irinotecan starting dose of 180 mg/m² adminstered via IV infusion

Study Details

This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in metastatic colorectal carcinoma (mCRC) patients with wild-type Kirsten rat sarcoma-2 virus oncogene (KRAS) tumor status at the time of initial diagnosis.

Key Dates

Start date
May 5, 2009
Status verified
Jun 2024
Primary completion
Jul 22, 2013
Completion
Jul 22, 2013

Study Design

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

Arms

  • Experimental: Panitumumab
    Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.

Primary Outcome Measure

PFS Hazard Ratio [ Time Frame: From baseline up to 152 weeks (from baseline to the time of the second biopsy prior to entering part 2) . ]

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