Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

January 25, 2017 updated by: PharmaMar

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Advanced Solid Tumors

Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntarily signed written informed consent
  • Age ≥ 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1.
  • Life expectancy ≥ 3 months.
  • Patients with confirmed diagnosis of advanced solid tumors.
  • Patients may have received ≤ 2 chemotherapy-containing lines in the advanced setting.
  • Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ seven days before inclusion in the study)
  • Recovery or stabilization to grade ≤ 1 from any adverse event derived from previous treatment (up to grade 2 alopecia or asthenia/fatigue are allowed).
  • No clinically significant changes in ECG.
  • At least four weeks since the last monoclonal antibody containing therapy or definitive radiotherapy (RT)
  • At least two weeks since the last biological/investigational single-agent therapy (excluding MAbs) and/or palliative RT (≤10 fractions or ≤30 Gy total dose)
  • Fertil women must have pregnancy excluded by appropriate testing before study entry

Exclusion Criteria:

  • Prior treatment with PM01183 or trabectedin.

  • Concomitant diseases/conditions:

    • 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, non-neoplastic, chronically active liver disease of any origin.
    • Active infection.
    • Patients who are requiring any ongoing oxygen support.
    • Known human immunodeficiency virus (HIV) infection.
    • Any other major illness.
  • Symptomatic or corticosteroid-requiring brain metastases or leptomeningeal disease involvement. Patients with asymptomatic documented stable brain metastases not requiring corticosteroids during the last three months are allowed.
  • Peripheral sensory/motor neuropathy grade >1. Hearing impairment grade >1.
  • Fertile men or women not using an effective method of contraception.
  • History of bone marrow or stem cell transplantation
  • Radiotherapye to >35% of the bone marrow.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lurbinectedin (PM01183) / cisplatin
Patients will receive cisplatin as a 90-min i.v. infusion. In addition, patients will receive PM01183 as an i.v. infusion over 1-hour.
Drug: lurbinectedin (PM01183)
lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
Drug: Cisplatin
vials containing 1 mg/ml concentrate for solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended dose (RD) of the combination PM01183 and cisplatin
Time Frame: 30 months
To determine the recommended dose (RD) of PM01183 in combination with cisplatin every three weeks (q3wk) with or without aprepitant in patients with advanced solid tumors. The RD will be the dose level (DL) immediately below the maximum tolerated dose (MTD), that is, the highest DL explored at which less than one third of evaluable patients experience a DLT during Cycle 1.
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) characterisation of Cmax (maximum concentratio), AUC (area under the curve), CL (clearance), HL (half life) y Vss (volume of distribution)
Time Frame: 30 months
To characterize the pharmacokinetics (PK) parameters Cmax (maximum concentratio), AUC (area under the curve), CL (clearance), HL (half life) y Vss (volume of distribution ) of this combination in patients receiving/not receiving aprepitant and to explore factors that may affect individual variability in main PK parameters.
30 months
Pharmacogenomic (PGx) analysis
Time Frame: 30 months
To conduct an exploratory pharmacogenomic (PGx) analysis to identify and validate putative molecular markers associated with the clinical outcome of patients treated with PM01183 and cisplatin. These molecular markers would help in the future selection of patients who might preferentially benefit from PM01183 therapy, thus contributing to improve health care through a more individualized medicine.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaMar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 30, 2014

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

January 5, 2017

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM1183-A-008-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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