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

Pancreatic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210364
• Other study ID #: PM1183-A-006-12
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2014
• Last updated: December 13, 2016
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: PharmaMar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPSpain: Agencia Española de Medicamentos y Productos SanitariosUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Metastatic Breast Cancer
• Metastatic Colorectal Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• lurbinectedin (PM01183)
lurbinectedin (PM01183) 1 mg and 4 mg vials
• capecitabine
capecitabine 150 mg tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PharmaMar

Countries where clinical trial is conducted

Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended dose of PM01183 in combination with capecitabine		30 months	Yes