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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: Completed Phase 1 study, sponsored by PharmaMar.
NCT02533674 is a Phase 1 study that has completed, run by PharmaMar. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose-limiting toxicities were defined as: * Grade 4 neutropenia lasting \>3 days * Grade≥3 febrile neutropenia of any duration or neutropenic sepsis * Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion * Grade 4 ALT/AST increase, or grade 3 lasting \>7 days * Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP * Any other grade≥3 non-hematological AE that was suspected to be related to st
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 |
What the finished NCT02533674 record still lists
NCT02533674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Gemcitabine plus PM060184 is the first listed.
NCT02533674 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02533674's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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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