Study Of Lurbinectedin (PM01183) In Combination With Capecitabine In Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) Or Metastatic Colorectal Cancer (CRC).

Study Overview

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) 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.

N/A

Metastatic Breast Cancer
Pancreatic Cancer
Metastatic Colorectal Cancer

DRUG: lurbinectedin (PM01183)
DRUG: capecitabine

PM1183-A-006-12

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-08-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-12-13
First Submitted that Met QC Criteria 2014-08-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-12-14
First Posted (ESTIMATED) 2014-08-06	Results First Posted N/A	Last Verified 2016-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: lurbinectedin (PM01183) and capecitabine	DRUG: lurbinectedin (PM01183) lurbinectedin (PM01183) 1 mg and 4 mg vials DRUG: capecitabine capecitabine 150 mg tablets

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: lurbinectedin (PM01183) and capecitabine

DRUG: lurbinectedin (PM01183)

lurbinectedin (PM01183) 1 mg and 4 mg vials

DRUG: capecitabine

capecitabine 150 mg tablets

Primary Outcome Measures	Measure Description	Time Frame
Recommended dose of PM01183 in combination with capecitabine		30 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record