Phase 1 and 2 Study of PX-866 and Cetuximab
Public ClinicalTrials.gov record NCT01252628. 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
Phase 1/2 Study of PX-866 and Cetuximab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of PX-866 to be given in combination with cetuximab will be determined in patients with incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase 2 part of the study is a randomized evaluation of the antitumor activity and safety of PX-866 in combination with cetuximab versus cetuximab alone in patients with either 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 incurable progressive, recurrent or metastatic SCCHN (Group 2).
Study identification
- NCT ID
- NCT01252628
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 178 participants
Conditions and interventions
Conditions
Interventions
- PX-866 (SCCHN) Drug
- Cetuximab (SCCHN) Drug
- PX-866 (CRC) Drug
- Cetuximab (CRC) Drug
Drug
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
- Nov 30, 2010
- Primary completion
- Oct 31, 2013
- Completion
- Dec 31, 2013
- Last update posted
- May 15, 2018
2010 – 2014
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Hematology and Oncology Assocs. | Birmingham | Alabama | 35223 | — |
| University of Alabama Birmingham | Birmingham | Alabama | 35249 | — |
| Southwest Cancer Care | Escondido | California | 92025 | — |
| Monterey Bay Oncology | Monterey | California | 93940 | — |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Eastern Colorado Health Care System - (Denver VA) | Denver | Colorado | 80220 | — |
| George Washington University - Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Integrated Community Oncology Network | Jacksonville | Florida | 32256 | — |
| Advanced Medical Specialties | Miami | Florida | 33176 | — |
| Pasco Pinellas Cancer Center | New Port Richey | Florida | 34652 | — |
| Peachtree Hematology-Oncology Consultants | Atlanta | Georgia | 30318 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Saint Louis Cancer Care LLP | Bridgeton | Missouri | 63044 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Mary Crowley Cancer Center | Dallas | Texas | 75230 | — |
| Texas Oncology - Baylor Charles A. Sammons | Dallas | Texas | 75246 | — |
| Texas Oncology - Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Oncology - Seton Williamson | Round Rock | Texas | 78665 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | — |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | — |
| Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | — |
| Columbia Basin Hematology and Oncology | Kennewick | Washington | 99336 | — |
| Medical Oncology Associates | Spokane | Washington | 99208 | — |
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 NCT01252628, 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 May 15, 2018 · Synced Sep 10, 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 protocol, eligibility criteria, and contact information for NCT01252628 live on ClinicalTrials.gov.