Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT02210364
First received: August 5, 2014
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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 optimizatio, 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 Intervention Phase
Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).
Drug: lurbinectedin (PM01183)
Drug: capecitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • Recommended dose of PM01183 in combination with capecitabine [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lurbinectedin (PM01183) and capecitabine Drug: lurbinectedin (PM01183)
lurbinectedin (PM01183) 1 mg and 4 mg vials
Drug: capecitabine
capecitabine 150 mg tablets

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02210364

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

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02210364     History of Changes
Other Study ID Numbers: PM1183-A-006-12 
Study First Received: August 5, 2014
Last Updated: May 12, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 25, 2016