Platinum-Resistant / Refractory Advanced Ovarian Cancer. MedDRA version: 14.0 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: PM01183
Product Code: PM01183
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Not applicable
CAS Number: 497871-47-3
Current Sponsor code: PM01
Sponsors
Pharma Mar S.A. Sociedad Unipersonal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Voluntary written informed consent (IC) before any study-specific procedure. -Confirmed epithelial ovarian cancer. -FIGO stages IIC and measurable disease. -Platinum-resistant / refractory disease. -Less than three prior lines of chemotherapy. -Age> = 18 years. -ECOG performance status (PS) =65 years) yes F.1.3.1 Number of subjects for this age range 39
Exclusion criteria
Exclusion criteria: -Concomitant diseases / conditions. -Platinum-sensitive disease. -Prior treatment with Topotecan. -Hipersensitivity to topotecan. -Known or suspected brain metastases or leptomeningeal disease. -Women who are pregnant or breast feeding. -Prior pelvic irradiation with total doses >=45 Grays (Gy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antitumor activity of PM01183 in patients with platinum-resistant / refractory advanced ovarian cancer.;Secondary Objective: To analyze: -Progression free survival (PFS) -Overall survival (OS) -Antitumor activity of Topotecan or PLD as control arms, if the study proceeds onto the second stage. -Safety profile of PM01183. -Pharmacokinetic. -To correlate molecular parameters found in the tumor samples of patients with PM01183 treatment.;Primary end point(s): To evaluate the antitumor activity of PM01183 in patients with platimun-resistant / refractory advanced ovarian cancer.;Timepoint(s) of evaluation of this end point: Evaluation during 33 months which is the duration of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To analyze: -Progression free survival (PFS) and overall survival (OS). -Antitumor activity of topotecan or pegylated liposomal doxorubicin (PLD) as control arms. -Safety profile of PM01183. -Pharmacokinetic / Pharmacodynamic. To correlate molecular parameters found in the tumor samples.;Timepoint(s) of evaluation of this end point: Evaluation during 33 months which is the duration of the study. | — |
Countries
Spain
Contacts
Public ContactClinical Trials
Pharma Mar S.A. Sociedad Unipersonal
Outcome results
None listed