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Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors

NCT02533674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-06-11

Study results available
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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.

Conditions

Interventions

DRUG

Gemcitabine plus PM060184

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-12
Primary Completion
2019-07-11
Completion
2019-07-11

Countries

  • United States
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533674 on ClinicalTrials.gov