Back to resultsStudy of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
Primary Purpose
Metastatic Breast Cancer, Pancreatic Cancer, Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
lurbinectedin (PM01183)
capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lurbinectedin (PM01183) and capecitabine
Arm Description
Outcomes
Primary Outcome Measures
Recommended dose of PM01183 in combination with capecitabine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02210364
Brief Title
Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaMar
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Pancreatic Cancer, Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lurbinectedin (PM01183) and capecitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lurbinectedin (PM01183)
Intervention Description
lurbinectedin (PM01183) 1 mg and 4 mg vials
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Description
capecitabine 150 mg tablets
Primary Outcome Measure Information:
Title
Recommended dose of PM01183 in combination with capecitabine
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Brussels
Country
Belgium
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
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