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NCT03310632 · ClinicalTrials.gov registry record · Phase 1
Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
A Phase 1 study, sponsored by Golden Biotechnology Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT03310632: Completed Phase 1 study, sponsored by Golden Biotechnology Corporation.
NCT03310632 is a Phase 1 study that has completed, run by Golden Biotechnology Corporation. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03310632, a Phase 1 study, has completed, sponsored by Golden Biotechnology Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD (based on PK and capsules strength) of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine. The extended Phase II will focus on the efficacy of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the proposed clinical trial.
Primary Outcome
For phase I: The MTD is the dose at which \<33% of patients experience a dose limiting toxicity (DLT) within the first 28-day cycle of antroquinonol and nab-paclitaxel + gemcitabine combined treatment.
Interventions
- DRUG Antroquinonol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2024-01-02 |
| Phase | Phase 1 |
What the finished NCT03310632 record still lists
NCT03310632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Antroquinonol is the first listed.
NCT03310632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03310632 about?
NCT03310632 is a clinical study titled "Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer". Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. The first part of st...
What is the current status of trial NCT03310632?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2017-12-01. Estimated completion is 2024-01-02.
What interventions are being tested in trial NCT03310632?
The interventions under investigation include: Antroquinonol (DRUG).
Who is sponsoring clinical trial NCT03310632?
This trial is sponsored by Golden Biotechnology Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03310632's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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