Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced SolidTumors.

Phase 1

• Conditions: Selected Advanced Solid Tumors.; MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003773-42-DE
• Lead Sponsor: Pharma Mar S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-20
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1)Age >/= 18 years.
2)Voluntary signed informed consent (IC) of the patient before any study-specific procedure.
3)Pathologically proven diagnosis of any of the following malignancies:
a)Small cell lung cancer (SCLC).
b)Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
c)Neuroendocrine tumors (NETs), grade 2 and 3 according to World
Health Organization (WHO) classification.
d)Biliary tract carcinoma.
e)Endometrial carcinoma.
f)BRCA 1/2- associated metastatic breast carcinoma.
g)Carcinoma of unknown primary site.
h)Germ cell tumor (GCTs), excluding immature teratoma, or teratoma
with malignant transformation.
i)Ewing's family of tumors (EFTs).4)Prior treatment. Patients must have received:
a)SCLC: one prior chemotherapy-containing line.
b)H&N: one or two prior chemotherapy-containing lines.
c)NETs: one or two prior chemotherapy-containing lines. No more than three prior hormone or biological therapy lines.
d)Biliary tract carcinoma: one or two prior chemotherapy-containing
lines.
e)Endometrial carcinoma: one prior chemotherapy-containing line.
f)BRCA 1/2-associated metastatic breast carcinoma: at least one but no
more than three prior chemotherapy-containing lines.
g)Carcinoma of unknown primary site: one or two prior chemotherapycontaining
lines.
h)GCTs: no limit of prior therapy (patients with no other clinical
therapeutic options).
i)EFTs: no more than two prior chemotherapy-containing lines in the
metastatic/recurrent setting.
5)Measurable disease as defined by RECIST v.1.1, and documented
progression before study entry.
6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 7)Adequate major organ function:
a)Hemoglobin >/= 9 g/dl, prior red blood cell (RBC) transfusions are
allowed if clinically indicated; absolute neutrophil count (ANC) >/= 2.0 x 109/l; and platelet count >/= 100 x 109/l.
b)Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) c)Total bilirubin d)Albumin >/= 3 g/dl.
e)Serum creatinine /= 30 ml/min.
f)Creatine phosphokinase (CPK) 8)Washout periods prior to Day 1 of Cycle 1:
a)At least three weeks since the last chemotherapy (six weeks if therapy contained nitrosureas or systemic mitomycin C).
b)At least four weeks since the last monoclonal antibody (MAb)-containing therapy, or radiotherapy (RT) > 30 gray (Gy).
c)At least two weeks since the last biological/investigational therapy
(excluding MAbs) or palliative RT (9)Grade 10)Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry. Fertile women must agree to use a medically acceptable method of contraception throughout the treatment period and for at least three months after treatment
discontinuation. Fertile men must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 149
F.1.3 Elderly (>=65 years

Exclusion Criteria

1)Prior treatment with PM01183 or trabectedin.
2)Prior or concurrent malignant disease unless in complete remission for more than five years, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma.
3)Known central nervous system (CNS) involvement. In patients with
SCLC, brain computed tomography (CT)-scan or magnetic resonance
imaging(MRI) results must be provided at baseline.
4)Relevant diseases or clinical situations which may increase the
patient´s risk:
a)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.
b)Grade >/= 3 dyspnea or daily intermittent oxygen requirement within two weeks prior to the study treatment onset.
c)Active infection.
d)Unhealed wounds or presence of any external drainage.
e)Known chronic active hepatitis or cirrhosis.
f)Immunocompromised patients, including known infection by human
immunodeficiency virus (HIV).
5)Women who are pregnant or breast-feeding, and fertile patients (men and women) who are not using an effective method of contraception. *
6)Impending need for RT (e.g., painful bone metastasis and/or risk of
spinal cord compression).
7)Limitation of the patient's ability to comply with the treatment or to follow-up the protocol.
* Women of childbearing potential (WOCBP) must agree to use an effective contraception method to avoid pregnancy during the course of the trial (and for at least three months after the last infusion). Valid methods to determine the childbearing potential, adequate contraception and requirements for WOCBP partners are described in the study protocol, appendix 2. Fertile men must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified