Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.
- Conditions
- Selected Advanced Solid Tumors.MedDRA version: 19.1Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003773-42-BE
- Lead Sponsor
- Pharma Mar S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 325
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 grade 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 chemotherapycontaining line.
f) BRCA 1/2-associated metastatic breast carcinoma: at east 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: 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) = 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 or creatinine clearance =
30 ml/min.
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 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
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 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method