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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).

NCT02210364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-12-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

lurbinectedin (PM01183)

lurbinectedin (PM01183) 1 mg and 4 mg vials

DRUG

capecitabine

capecitabine 150 mg tablets

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02210364 on ClinicalTrials.gov