Skip to main content
OpenTrials
Completed

NCT Number: NCT01980667

Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bellinzona, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lurbinectedin (PM01183)

Drug

lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.

Cisplatin

Drug

vials containing 1 mg/ml concentrate for solution for infusion

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2013
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.