A phase II non-randomised, open-label, single-arm study to assess the efficacy, safety and tolerability of Nexavar ® (Sorafenib) monotherapy as third line therapy in patients with progressed ovarian epithelial or primary peritoneal cancer. - OCCASIONE

• Conditions: 1. progressed ovarian epithelial cancer2. primary peritoneal cancer; MedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer

• Registration Number: EUCTR2008-002156-14-PL
• Lead Sponsor: FUNDATION OF EXPERIMENTAL AND CLINICAL ONCOLOGY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Female patient = 18 years old.
2. Histologically or cytologically confirmed ovarian epithelial or primary peritoneal cancer.
3. Recurrent or refractory disease.
4. Prior chemotherapy regimens (e.g., initial chemotherapy platinum-based and 1 regimen for subsequent relapse or due to resistance for initial CHT). Each subject must receive regimen based on platinum analogs (carboplatin AUC 5-6 or cisplatin 75 mg/ m2) and paclitaxel based regimen. It could be patients with refractory ovarian cancer (< 6 months to relapse or progression or without any clinical response) or sensitive (> 6 months), the prior chemotherapy must be finished at least 4 weeks before starting of sorafenib treatment.
6. If measurable disease is in a previously irradiated site, there must be disease progression in that lesion 6 months after completion of radiotherapy.
7. ECOG performance status 0 – 2.
8. Female patients must be using effective contraception, be surgically sterile or be postmenopausal. All at-risk female patients must have a negative serum pregnancy test within 7 days prior to study drug administration.
9. Patients with adequate bone marrow, liver and renal function.
10. Signed informed consent must be obtained prior to any study specific procedures.

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

1. Known or suspected allergy to the investigational agent or any agent given in association with the trial.
2. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta,Tis,T1) or any cancer curatively treated >3 years prior to study entry.
3. History of cardiac disease.
4. History of HIV infection or chronic hepatitis B or C.
5. Active clinically serious infections.
6. Symptomatic metastatic brain ot meningeal tumors
7. Seizure disorders requiring medications.
8. History of organ allograft or patients undergoing renal dialysis
9. Thrombotic or embolic events.
10.Pregnant or breast-feeding patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to demonstrate the progression free survival – PFS.;Secondary Objective: The secondary objective is time to progression – TTP, duration of response, overall survival – OS, clinical benefit – CB = CR + PR + SD, safety and tolerability (adverse events, toxicity, vital signs, laboratory abnormalities).;Primary end point(s): Evaluation of progression free survival.