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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).

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ClinicalTrials.gov Identifier: NCT02210364
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
PharmaMar

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Pancreatic Cancer Metastatic Colorectal Cancer Drug: lurbinectedin (PM01183) Drug: capecitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 :
  1. Recommended dose of PM01183 in combination with capecitabine [ Time Frame: 30 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210364


Locations
Belgium
Brussels, Belgium
Spain
Barcelona, Spain
Sponsors and Collaborators
PharmaMar

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02210364     History of Changes
Other Study ID Numbers: PM1183-A-006-12
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents