NCT02210364

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2013

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 14, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

August 5, 2014

Last Update Submit

December 13, 2016

Conditions

Metastatic Breast CancerPancreatic CancerMetastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Recommended dose of PM01183 in combination with capecitabine

    30 months

Study Arms (1)

lurbinectedin (PM01183) and capecitabine

EXPERIMENTAL
Drug: lurbinectedin (PM01183)Drug: capecitabine

Interventions

lurbinectedin (PM01183)DRUG

lurbinectedin (PM01183) 1 mg and 4 mg vials

lurbinectedin (PM01183) and capecitabine
capecitabineDRUG

capecitabine 150 mg tablets

lurbinectedin (PM01183) and capecitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Barcelona, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsPancreatic NeoplasmsColorectal Neoplasms

Interventions

PM 01183Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 6, 2014

Study Start

April 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 14, 2016

Record last verified: 2016-05

Locations

BE(1)ES(1)