Overview

This trial has been completed.

Conditions metastatic breast cancer, pancreatic cancer, metastatic colorectal cancer
Treatments lurbinectedin (pm01183), capecitabine
Phase phase 1
Sponsor PharmaMar
Start date April 2013
End date October 2016
Trial size 81 participants
Trial identifier NCT02210364, PM1183-A-006-12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lurbinectedin (pm01183)
lurbinectedin (PM01183) 1 mg and 4 mg vials
capecitabine
capecitabine 150 mg tablets

Primary Outcomes

Measure
Recommended dose of PM01183 in combination with capecitabine
time frame: 30 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by PharmaMar.