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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 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 9 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01187615
The ClinicalTrials.gov registry entry for NCT01187615 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed is the first listed.
NCT01187615 reports 0 study locations.
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.
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