Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT02448810. 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 2a Randomized, Open-label Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination With 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as third or fourth treatment line in subjects with progressive measurable metastatic colorectal cancer (mCRC).
Study identification
- NCT ID
- NCT02448810
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 115 participants
Conditions and interventions
Conditions
Interventions
- BAX69 + infusional 5-FU/LV Biological
- BAX69 + panitumumab Biological
- BAX69 + 5-FU/LV Biological
- Standard of Care Drug
- Standard of Care Biological
Biological · 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
- Jun 15, 2015 (Actual)
- Primary completion
- Feb 15, 2017 (Actual)
- Completion
- Feb 15, 2017 (Actual)
- Last update posted
- May 25, 2021
2015 – 2017
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | 60435 | — |
| Indiana University Health | Goshen | Indiana | 46526 | — |
| Maryland Oncology Hematology, P.A. | Rockville | Maryland | 20850 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | 10461 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29412 | — |
| The Jones Clinic, PC | Germantown | Tennessee | 38138 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75230 | — |
| CTRC at University of Texas Health Science Center | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02448810, 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 25, 2021 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02448810 live on ClinicalTrials.gov.