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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 is a Phase 2 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 115 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02448810
The ClinicalTrials.gov registry entry for NCT02448810 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Standard of Care is the first listed.
NCT02448810 reports 0 study locations.
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.
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