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NCT01187615 · ClinicalTrials.gov registry record · Phase 1
Determination of Safety, Efficacy, and Pharmacokinetics of "Regorafenib" Combined With Pemetrexed and Cisplatin in Patients With Nonsquamous Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01187615: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT01187615 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01187615, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, non-randomized Phase I study to define the safety profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or Stage IV nonsquamous Non-Small Cell Lung Cancer (NSCLC) and to determine the impact of the combined administration on the pharmacokinetics of regorafenib, pemetrexed, and cisplatin. In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break. In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21. Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing.
Interventions
- DRUG Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed
- DRUG Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
Why NCT01187615 stopped before completion
NCT01187615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed is the first listed.
NCT01187615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01187615 about?
NCT01187615 is a clinical study titled "Determination of Safety, Efficacy, and Pharmacokinetics of "Regorafenib" Combined With Pemetrexed and Cisplatin in Patients With Nonsquamous Non-Small Cell Lung Cancer". This is a multi-center, open-label, non-randomized Phase I study to define the safety profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or Stage IV nonsquamous Non-Small Cell Lung Ca...
What is the current status of trial NCT01187615?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-08. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01187615?
The interventions under investigation include: Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed (DRUG), Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT01187615?
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 NCT01187615's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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