Platinum-resistant ovarian cancer MedDRA version: 17.1 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Lurbinectedin
Product Code: PM01183
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: LURBINECTEDIN
CAS Number: 497871-47-3
Current Sponsor code:
Sponsors
Pharma Mar S.A., Sociedad Unipersonal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntary written informed consent (IC) of the patient obtained before any study-specific procedure. 2) Age = 18 years. 3) Histologically or cytologically confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer. 4) Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy). 5) Radiologically measurable and/or non-measurable progressive disease according to RECIST v 1.1. 6) No more than three prior systemic chemotherapy regimens. Note: in case that a patient had started a new systemic chemotherapy without disease progression to the prior chemotherapy line (e.g., treatment discontinuations due to toxicity; neoadjuvant followed by adjuvant chemotherapy regimens), these two chemotherapy regimens will considered as one. 7) ECOG PS = 2. 8) Adequate hematological, renal, metabolic and hepatic function: a) Hemoglobin = 9 g/dl [patients may have received prior red blood cell (RBC) transfusion]; 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) Alkaline phosphatase (AP) ULN. e) Albumin = 3.0 g/dl. f) Calculated creatinine clearance (CrCL) = 30 ml/min (using Cockcroft and Gault's formula). g) Creatine phosphokinase (CPK) = 2.5 x ULN. 9) At least three weeks since last prior therapy, and grade = 1 from any adverse event (AE) derived from previous treatment (excluding grade = 2 alopecia or peripheral neuropathy) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v. 4). 10) Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry. A medically acceptable method of contraception must be maintained throughout the treatment period and for at least six months 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 294 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: 1) Concomitant diseases/conditions: a) History of cardiac disease: myocardial infarction or symptomatic/uncontrolled angina within the year prior to enrollment; or congestive heart failure defined as abnormal left ventricular ejection fraction (LVEF) 6 months). 3) Prior treatment with PM01183, trabectedin, or with both PLD and topotecan. Note: if 60% of recruitment is reached in one of the control treatment options (i.e., PLD or topotecan), patients could only be eligible if they did not previously receive the other control treatment option available (the Sponsor will inform the sites, if this occurs). 4) Known brain metastases or leptomeningeal disease involvement. 5) History of another neoplastic disease (except for curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or properly treated carcinoma in situ of the uterine cervix or breast) within three years prior to randomization. 6) Pregnant or breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate: - Overall survival (OS). - Antitumor activity. - Safety profile. - Patient-reported outcomes (PRO). To characterize the plasma pharmacokinetics (PK) of PM01183 using a sparse sampling scheme in the PM01183 treatment arm (Arm A). Subgroup analyses of the PM01183 arm versus PLD or topotecan. To conduct an exploratory pharmacogenetic and pharmacogenomic (PGx) sub-study.;Main Objective: To determine a difference in progression-free-survival (PFS) between lurbinectedin (PM01183) and pegylated liposomal doxorubicin (PLD) or topotecan in platinum-resistant ovarian cancer patients according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.;Primary end point(s): Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: Along the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival (PFS) Overall survival (OS) Landmark analyses: PFS at 6 and 12 months by IRC/IA OS at 12 and 24 months Best antitumor response by IRC/IA Duration of response (DR) by IRC/IA Best response according to tumor marker evaluation (CA-125) Treatment safety profile Patient-reported outcomes (PRO): Plasma pharmacokinetics (PK) of PM01183 Subgroup analyses: Subgroup analyses of the PM01183 arm versus PLD or topotecan Pharmacogenetics Pharmacogenomics;Timepoint(s) of evaluation of this end point: Along the study | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Romania, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials
Pharma Mar S.A., Sociedad Unipersonal
Outcome results
None listed