Study of PM01183 in platinum-resistant / refractory advanced ovarian cancer patients.
- Conditions
- Platinum-Resistant / Refractory Advanced Ovarian Cancer.MedDRA version: 14.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-002172-16-ES
- Lead Sponsor
- Pharma Mar S.A. Sociedad Unipersonal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 78
-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) <=2.
-Adequate hematological, renal, metabolic and hepatic function.
-No prior or concurrent invasive malignant disease with the last three years.
-At least three weeks since last prior chemotherapy.
-Negative serum pregnancy test in women of childbearing potential.
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 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39
-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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the antitumor activity of PM01183 in patients with platinum-resistant / refractory advanced ovarian cancer.;Secondary Objective: To analyze:<br>-Progression free survival (PFS)<br>-Overall survival (OS)<br>-Antitumor activity of Topotecan or PLD as control arms, if the study proceeds onto the second stage.<br>-Safety profile of PM01183.<br>-Pharmacokinetic.<br>-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 Outcome Measures
Name Time Method Secondary end point(s): To analyze:<br>-Progression free survival (PFS) and overall survival (OS).<br>-Antitumor activity of topotecan or pegylated liposomal doxorubicin (PLD) as control arms.<br>-Safety profile of PM01183.<br>-Pharmacokinetic / Pharmacodynamic.<br>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.