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NCT01251640 · ClinicalTrials.gov registry record · Phase 1
Combination With Gemcitabine in Advanced Pancreatic Cancer
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT01251640: Completed Phase 1 study, sponsored by Bayer.
NCT01251640 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251640, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer. Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose. Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability. Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
Interventions
- DRUG BAY86-9766+Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2011-01-01 |
| Est. Completion | 2013-08-01 |
| Phase | Phase 1 |
What the finished NCT01251640 record still lists
NCT01251640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which BAY86-9766+Gemcitabine is the first listed.
NCT01251640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01251640 about?
NCT01251640 is a clinical study titled "Combination With Gemcitabine in Advanced Pancreatic Cancer". Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer. Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximu...
What is the current status of trial NCT01251640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2011-01-01. Estimated completion is 2013-08-01.
What interventions are being tested in trial NCT01251640?
The interventions under investigation include: BAY86-9766+Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01251640?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01251640's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 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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