Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.

Phase 1

• Conditions: Selected Advanced Solid Tumors.; MedDRA version: 18.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003773-42-SE
• Lead Sponsor: Pharma Mar S.A. Sociedad Unipersonal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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 and oropharynx carcinoma are excluded.
c)Neuroendocrine tumors (NETs), excluding carcinoid tumors.
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 pure teratocarcinoma.
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 prior chemotherapy-containing line. No more than three prior hormone or biological therapy lines.
d)Biliary tract carcinoma: one prior chemotherapy-containing line.
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 chemotherapy-containing lines.
h)GCTs: no limit of prior therapy (patients with no other clinical therapeutic options).
i)EFTs: two prior chemotherapy-containing lines.
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)= 2.
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) = 3.0 x upper limit of normal (ULN).
c)Total bilirubin = 1.5 x ULN, or direct bilirubin = ULN.
d)Albumin = 3 g/dl.
e)Serum creatinine = 1.5 x ULN.
f)Creatine phosphokinase (CPK) = 2.5 x ULN.
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 (= 10 fractions or = 30 Gy total dose).
9)Grade = 1 toxicity due to any previous cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.4). Grade 2 is allowed in case of alopecia and/or peripheral sensory neuropathy.
10)Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry. Fertile women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation.
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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

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 results must be provided at baseline.
4)Relevant diseases or clinical situations which may increase the patients 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)Pregnant or breastfeeding women.
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.

Study & Design

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