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

Sponsor

PharmaMar (Industry)

Overall Status

Completed

CT.gov ID

NCT02210364

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

40.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer Pancreatic Cancer Metastatic Colorectal Cancer	Drug: lurbinectedin (PM01183) Drug: capecitabine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lurbinectedin (PM01183) and capecitabine	Drug: lurbinectedin (PM01183) lurbinectedin (PM01183) 1 mg and 4 mg vials Drug: capecitabine capecitabine 150 mg tablets

Arm

Intervention/Treatment

Experimental: lurbinectedin (PM01183) and capecitabine

Drug: lurbinectedin (PM01183)

lurbinectedin (PM01183) 1 mg and 4 mg vials

Drug: capecitabine

capecitabine 150 mg tablets

Outcome Measures

Primary Outcome Measures

Recommended dose of PM01183 in combination with capecitabine [30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Brussels		Belgium
2		Barcelona		Spain

Sponsors and Collaborators

PharmaMar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PharmaMar

ClinicalTrials.gov Identifier:

NCT02210364

Other Study ID Numbers:

PM1183-A-006-12

First Posted:

Aug 6, 2014

Last Update Posted:

Dec 14, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2016