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NCT02533674 · ClinicalTrials.gov registry record · Phase 1
Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by PharmaMar.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT02533674 is a Phase 1 study that has completed, run by PharmaMar. The registered enrollment target is 57 participants.
The verdict
NCT02533674, a Phase 1 study, has completed, sponsored by PharmaMar.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. The study objectives are: To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. To characterize the safety profile and feasibility of this combination in this study population. To characterize the pharmacokinetics of this combination and to detect major drug-drug PK interactions. To obtain preliminary information on the clinical antitumor activity of this combination.
Interventions
- DRUG Gemcitabine plus PM060184
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2019-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02533674
The ClinicalTrials.gov registry entry for NCT02533674 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmaMar, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine plus PM060184 is the first listed.
NCT02533674 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02533674 about?
NCT02533674 is a clinical study titled "Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors". Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. The study objectives are: To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected pat...
What is the current status of trial NCT02533674?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2014-12-12. Estimated completion is 2019-07-11.
What interventions are being tested in trial NCT02533674?
The interventions under investigation include: Gemcitabine plus PM060184 (DRUG).
Who is sponsoring clinical trial NCT02533674?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
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