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NCT02077998 · ClinicalTrials.gov registry record · Early Phase 1
Oxaliplatin in Treating Patients With Metastatic Breast Cancer
A Early Phase 1 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT02077998: Completed Early Phase 1 study, sponsored by University of California, Davis.
NCT02077998 is a Early Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 1 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02077998, a Early Phase 1 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and blood and the side effects and how well oxaliplatin works in treating patients with metastatic breast cancer. DNA analysis of tumor tissue and blood samples from patients receiving carbon C 14 oxaliplatin may help doctors predict how well patients will respond to treatment with oxaliplatin. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Primary Outcome
The concentration of oxaliplatin-DNA adducts induced will be characterized using descriptive statistics (graphical summaries, mean, standard deviation \[SD\], box plots) in PBMC and tumor for responders and non-responders to chemotherapy. The mean level of oxaliplatin-DNA adducts will be compared in responders to chemotherapy to that of non-responders using a 2-sample t-test at the 0.05 level (2-sided). The Youden index will be used to estimate and compute a 95% confidence interval for the optim
Interventions
- OTHER laboratory biomarker analysis
- DRUG oxaliplatin
- RADIATION carbon C 14 oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-05 |
| Est. Completion | 2015-12 |
| Phase | Early Phase 1 |
What the finished NCT02077998 record still lists
NCT02077998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT02077998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02077998 about?
NCT02077998 is a clinical study titled "Oxaliplatin in Treating Patients With Metastatic Breast Cancer". This phase 0/II trial studies the effect of carbon C 14 oxaliplatin in tumor tissue and blood and the side effects and how well oxaliplatin works in treating patients with metastatic breast cancer. DNA analysis of tumor tissue and blood samples from patients receiving carbon C 14 oxaliplatin may hel...
What is the current status of trial NCT02077998?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2015-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02077998?
The interventions under investigation include: laboratory biomarker analysis (OTHER), oxaliplatin (DRUG), carbon C 14 oxaliplatin (RADIATION).
Who is sponsoring clinical trial NCT02077998?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02077998's enrollment target sits among peer trials
1 1986th of 2000 the lowest of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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