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NCT00619424 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study Of Pazopanib With Either Erlotinib Or Pemetrexed In Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT00619424 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 58 participants.
The verdict
NCT00619424, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) of pazopanib in combination with erlotinib (Arm A) or pazopanib in combination with pemetrexed (Arm B) in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 (in each arm) to receive escalating doses of pazopanib and erlotinib or pazopanib and pemetrexed. Dose escalation schemas for each study arm are described in the protocol. For each arm, the MTD regimen will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the MTD regimen to evaluate toxicity and pharmacokinetics. In arm A (erlotinib), a run-in phase with each drug separately will allow an evaluation of pharmacokinetics with each drug separately and also for the two drugs in combination. This will allow an assessment of potential drug-drug interactions. Pharmacokinetic endpoints will be AUC, Cmax, tmax and t1/2 of pazopanib, erlotinib, and pemetrexed, as well as pemetrexed clearance before and after administration of pazopanib in the extension cohort of Arm B. Antitumor activity will be assessed using RECIST criteria.
Interventions
- DRUG pemetrexed
- DRUG pazopanib
- DRUG erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2007-11-15 |
| Est. Completion | 2009-09-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00619424
The ClinicalTrials.gov registry entry for NCT00619424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which pemetrexed is the first listed.
NCT00619424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00619424 about?
NCT00619424 is a clinical study titled "A Phase I Study Of Pazopanib With Either Erlotinib Or Pemetrexed In Patients With Advanced Solid Tumors". This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) of pazopanib in combination with erlotinib (Arm A) or pazopanib in combination with pemetrexed (Arm B) in patients with advanced solid tumors. Pati...
What is the current status of trial NCT00619424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2007-11-15. Estimated completion is 2009-09-04.
What interventions are being tested in trial NCT00619424?
The interventions under investigation include: pemetrexed (DRUG), pazopanib (DRUG), erlotinib (DRUG).
Who is sponsoring clinical trial NCT00619424?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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