Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. MedDRA version: 14.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedD
Conditions
Interventions
Product Name: Paclical®
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069624
Concentration unit: mg/m2 milligram(s)/square meter
Concentration typ
Sponsors
Oasmia Pharmaceutical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. 2.Patients relapsing > 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis. 3.CA 125 >2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non-measurable disease. 4.Age > 18 years. 5.Eastern Cooperative Oncology Group (ECOG) performance score 0-2. 6.Life expectancy >12 weeks. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patient has peripheral neuropathy of grade = 2 per NCI-CTCAE version 3.0. 2.Surgical procedure due to progressive disease within 4 weeks of any of the CA-125 measurements. 3.Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1 , Cycle 1). 4.Bowel obstruction at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To show non-inferiority of the experimental treatment and the control treatment in terms of the change in AUC based treatment Cav of CA 125 relative to predose Cav of CA 125. • To show non-inferiority of the experimental treatment and the control treatment in terms of progression free survival (PFS) using CT scans according to Response Criteria in Solid Tumors, RECIST, as assessed by central review. • To show superiority of the experimental treatment over the control treatment in terms of the incidence and severity of hypersensitivity reactions.;Secondary Objective: Compare between treatment arms: • Response rate (RR) using CA125 • Overall response rate using CT scan • ECOG performance score • Safety and tolerability • Pharmacokinetics of total and unbound paclitaxel and carboplatin in a subset of patients;Primary end point(s): • Change in AUC based treatment Cav of CA 125 relative to predose Cav of CA 125. • Progression free survival (PFS) using CT scans according to Response Criteria in Solid Tumors, RECIST. • Incidence and severity of hypersensitivity reactions.;Timepoint(s) of evaluation of this end point: CA 125 and PFS: During treatment and follow-up. Hypersensitivity: During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Response rate (RR) using CA125 • Overall response rate using CT scan • ECOG performance score • Safety and tolerability • Concentration of total and unbound paclitaxel and carboplatin, in a subset of patients;Timepoint(s) of evaluation of this end point: RR, overall RR and ECOG: During treatment and follow-up. Safety: During treatment and follow-up. Concentration of paclitaxel and carboplatin: During and after administration. | — |
Countries
Belgium, Bulgaria, Czech Republic, Finland, Hungary, Latvia, Lithuania, Sweden
Contacts
Public ContactSponsor
Oasmia Pharmaceutical AB
Outcome results
None listed