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NCT02448810 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Terminated
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT02448810: Clinical Trial Phase 2 study, sponsored by Baxalta now part of Shire.
NCT02448810 is a Phase 2 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 115 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02448810, a Phase 2 study, was terminated before completion, sponsored by Baxalta now part of Shire.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
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).
Primary Outcome
PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.
Interventions
- DRUG Standard of Care
- BIOLOGICAL BAX69 + infusional 5-FU/LV
- BIOLOGICAL BAX69 + panitumumab
- BIOLOGICAL BAX69 + 5-FU/LV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2015-06-15 |
| Est. Completion | 2017-02-15 |
| Phase | Phase 2 |
Why NCT02448810 stopped before completion
NCT02448810 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 4 interventions - of which Standard of Care is the first listed.
NCT02448810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02448810 about?
NCT02448810 is a clinical study titled "Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer". 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 subj...
What is the current status of trial NCT02448810?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2015-06-15. Estimated completion is 2017-02-15.
What interventions are being tested in trial NCT02448810?
The interventions under investigation include: Standard of Care (DRUG), BAX69 + infusional 5-FU/LV (BIOLOGICAL), BAX69 + panitumumab (BIOLOGICAL), BAX69 + 5-FU/LV (BIOLOGICAL).
Who is sponsoring clinical trial NCT02448810?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02448810's enrollment target sits among peer trials
115 626th of 2000 higher than 1,374 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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