Status:
COMPLETED
Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
Lead Sponsor:
PharmaMar
Conditions:
Metastatic Breast Cancer
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT02210364
Start Date
April 1 2013
End Date
October 1 2016
Last Update
December 14 2016
Active Locations (2)
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1
Brussels, Belgium
2
Barcelona, Spain