Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
NCT ID: NCT02210364
Last Updated: 2016-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
81 participants
INTERVENTIONAL
2013-04-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lurbinectedin (PM01183) and capecitabine
lurbinectedin (PM01183)
lurbinectedin (PM01183) 1 mg and 4 mg vials
capecitabine
capecitabine 150 mg tablets
Interventions
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lurbinectedin (PM01183)
lurbinectedin (PM01183) 1 mg and 4 mg vials
capecitabine
capecitabine 150 mg tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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PharmaMar
INDUSTRY
Responsible Party
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Locations
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Brussels, , Belgium
Barcelona, , Spain
Countries
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Other Identifiers
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PM1183-A-006-12
Identifier Type: -
Identifier Source: org_study_id