Phase 1/2 Study of PX-866 and Cetuximab
Phase 1 will determine the maximally tolerated or recommended dose of PX-866 to be given
orally on Days 1-21 in combination with cetuximab 250 mg/m2 administered IV weekly on Days
1, 8, and 15 of a 21-day cycle. All patients will receive an initial loading dose of 400
mg/m2 cetuximab rather than 250 mg/m2 on Cycle 1 Day 1. Patients may receive premedication
with an H1 antagonist per the cetuximab package insert. Up to 3 dose levels of PX-866 will
be evaluated to determine the MTD/RD in cohorts of up to 6 patients using a standard 3+3
dose-escalation design. At least 6 patients will be treated at the MTD/RD. All patients in
Phase 1 will be required to undergo PK assessments during Cycle 1 Week 3 to measure
cetuximab levels. Exploratory PD assessments will include evaluation of changes in levels of
fasting C-peptide as well as changes in EGFR and PI-3K signaling pathways in peripheral
blood mononuclear cells (PBMC) and platelets. Additional optional evaluations will include
changes in EGFR and PI-3K signaling in paired tumor biopsies provided before and after one
cycle of treatment. All patients will be asked, but not required, to provide an archived
tumor biopsy sample for evaluation for potential biomarkers of response to PX-866 and
cetuximab.
Phase 2 is an open-label, randomized evaluation of the antitumor activity and safety of
PX-866 administered orally or via PEG tube (if applicable) at the MTD/RD in combination with
cetuximab, versus cetuximab alone in cetuximab-naïve patients with incurable metastatic CRC
who have a history of progression or recurrence following prior irinotecan and oxaliplatin
containing regimens or are intolerant of irinotecan (Group 1) or patients with incurable
progressive, recurrent or metastatic SCCHN (Group 2). Seventy two evaluable patients (36
patients per arm) will be evaluated per indication. Patients will be randomized 1:1 to
receive PX-866 + cetuximab or cetuximab alone.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The evaluation of antitumor effects of PX-866 in combination with cetuximab versus cetuximab in patients with incurable metastatic colorectal cancer and/or patients with incurable progressive, recurrent or metastatic SCC of the head and neck.
21 days
No
Diana Hausman, MD
Study Director
Oncothyreon Inc.
United States: Food and Drug Administration
PX-866-003
NCT01252628
December 2010
January 2014
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Southwest Cancer Care | Poway, California 92064 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Monterey Bay Oncology | Monterey, California 93940 |
Tufts Medical Center | Boston, Massachusetts 02111 |
University of Colorado Denver | Denver, Colorado 80262 |
Pasco Pinellas Cancer Center | New Port Richey, Florida 34652 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Ventura County Hematology Oncology Specialists | Oxnard, California 93030 |
MUSC Hollings Cancer Center | Charleston, South Carolina 29425 |
University of Alabama Birmingham | Birmingham, Alabama 35233 |
Advanced Medical Specialties | Miami, Florida 33176 |
Northwest Cancer Specialists, P.C. | Portland, Oregon 97227 |
Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
Peachtree Hematology-Oncology Consultants | Atlanta, Georgia 30309 |
Mary Crowley Cancer Center | Dallas, Texas 75246 |
Virginia Cancer Specialists, PC | Fairfax, Virginia 22031 |
Texas Oncology - Fort Worth | Fort Worth, Texas 76104 |
Medical Oncology Associates | Spokane, Washington 99208 |
Birmingham Hematology and Oncology Assocs. | Birmingham, Alabama 35223 |
Eastern Colorado Health Care System - (Denver VA) | Denver, Colorado 80220 |
George Washington University - Medical Faculty Associates | Washington, District of Columbia 20037 |
Saint Louis Cancer Care LLP | Bridgeton, Missouri 63044 |
Texas Oncology - Baylor Charles A. Sammons | Dallas, Texas 75246 |
Texas Oncology - Seton Williamson | Round Rock, Texas 78665 |
Oncology and Hematology Associates of Southwest Virginia | Roanoke, Virginia 24014 |