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OpenTrials
Completed

NCT Number: NCT02210364

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lurbinectedin (PM01183)

Drug

lurbinectedin (PM01183) 1 mg and 4 mg vials

Capecitabine

Drug

capecitabine 150 mg tablets

Primary outcomes

  1. Recommended dose of PM01183 in combination with capecitabine

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2014
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.