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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02210364
Other study ID # PM1183-A-006-12
Secondary ID
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


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
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