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COMPLETEDPHASE1

Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC)

NCT02210364•PharmaMar

View on ClinicalTrials.gov

Summary

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntarily signed and dated written informed consent (IC)
•Age between 18 and 75 years
•Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry.
•Life expectancy ≥ 3 months.
•Patients with a histologically/cytologically confirmed diagnosis of unresectable Metastatic Breast Cancer, Pancreatic Cancer or metastatic Colorectal Cancer.

Exclusion Criteria

•Three or more prior chemotherapy-containing lines for advanced disease.
•Prior treatment with PM01183 or with capecitabine containing therapy for advanced disease.
•History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
•Ongoing chronic hepatopathy of any origin.
•Active uncontrolled infection.
•Patients with dyspnea who are requiring any ongoing oxygen support.
•Known human immunodeficiency virus (HIV) infection.
•Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
•Men or women of childbearing potential who are not using an effective method of contraception

Locations (2)

Brussels, Belgium

Barcelona, Spain

Key Dates

Start Date

April 1, 2013

Primary Completion Date

October 1, 2016

Completion Date

October 1, 2016

Last Updated

December 14, 2016

Enrollment

ACTUAL participants

Conditions

Metastatic Breast CancerPancreatic CancerMetastatic Colorectal Cancer

Interventions

lurbinectedin (PM01183)

DRUG

capecitabine

DRUG

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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