Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Public ClinicalTrials.gov record NCT01309126. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination With Cetuximab (Erbitux®) in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study BT-CL-PGG-CRC1031 is a Phase 3, open-label, randomized, multi-center study. Qualified subjects, who have KRAS wild type (WT) colorectal cancer will be randomized in a 2:1 ratio to treatment with either Imprime PGG and cetuximab or cetuximab alone. Subjects will be dosed until progression or discontinuation for some other reason. Efficacy will be assessed via Response Evaluation Criteria in Early Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, pharmacokinetics (PK), quality of life, and biomarker parameters will also be assessed.
Study identification
- NCT ID
- NCT01309126
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 217 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2011 (Type not available)
- Primary completion
- Feb 2017 (Actual)
- Completion
- Feb 2017 (Actual)
- Last update posted
- Jul 13, 2017
2011 – 2017
United States locations
- U.S. sites
- 44
- U.S. states
- 22
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwest Alabama Cancer Center | Florence | Alabama | 35630 | — |
| Highlands Oncology Group | Bentonville | Arkansas | 72703 | — |
| Pacific Medical Center | Anaheim | California | 92801 | — |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | — |
| Providence St. Joseph Medical Center | Burbank | California | 91505 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92903 | — |
| Kenmar Research Institute | Los Angeles | California | 90057 | — |
| AMPM Research Clinic | Miami Gardens | Florida | 33169 | — |
| MD Anderson Cancer Center | Orlando | Florida | 32806 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Medical and Surgical Specialists | Galesburg | Illinois | 61401 | — |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | — |
| Indiana University Cancer Center | Beech Grove | Indiana | 46237 | — |
| University of Louisville/James Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Ellis Fischel Cancer Center at University of Missouri- Columbia | Columbia | Missouri | 65203 | — |
| Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| Hematology and Oncology Associates of Central NY | East Syracuse | New York | 13057 | — |
| New York Oncology, Hematology, P.C. | Hudson | New York | 12534 | — |
| Signal Point Hematology/Oncology | Middletown | Ohio | 45042 | — |
| Toledo Community Oncology Program- Toledo Community Hospital | Toledo | Ohio | 43623 | — |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Cancer Centers of the Carolinas | Spartanburg | South Carolina | 29307 | — |
| The Jones Clinic | Germantown | Tennessee | 38138 | — |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37915 | — |
| Texas Oncology-Amarillo | Amarillo | Texas | 79106 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75201 | — |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology Denton South | Denton | Texas | 76210 | — |
| Texas Oncology - Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Oncology - Lewisville | Lewisville | Texas | 75067 | — |
| Texas Oncology-Seton Williamson | Round Rock | Texas | 78665 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | — |
| Texas Oncology - Sherman | Sherman | Texas | 75090 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Northern Utah Associates | Ogden | Utah | 84403 | — |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | — |
| Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01309126, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2017 · Synced Oct 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01309126 live on ClinicalTrials.gov.