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

NCT ID: NCT01980667

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-30
• Study Completion Date: 2017-01-05

Brief Summary

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lurbinectedin (PM01183)

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

vials containing 1 mg/ml concentrate for solution for infusion

Interventions

lurbinectedin (PM01183)

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

Intervention Type: DRUG

Cisplatin

vials containing 1 mg/ml concentrate for solution for infusion

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bellinzona, , Switzerland

London, , United Kingdom

Newcastle, , United Kingdom

Countries

Switzerland; United Kingdom

References

Metaxas Y, Kahatt C, Alfaro V, Fudio S, Zeaiter A, Plummer R, Sessa C, Von Moos R, Forster M, Stathis A. A phase I trial of lurbinectedin in combination with cisplatin in patients with advanced solid tumors. Invest New Drugs. 2022 Feb;40(1):91-98. doi: 10.1007/s10637-021-01142-1. Epub 2021 Aug 28.

Reference Type: DERIVED

PMID: 34453241 (View on PubMed)

Other Identifiers

PM1183-A-008-13

Identifier Type: -

Identifier Source: org_study_id