A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer

Phase 3

Completed

• Conditions: ovariancarcinoma; 10038594

• Registration Number: NL-OMON31592
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. Histologically confirmed ovarium carcinoom.
2. Resistant / refractory to prior platinum-based chemotherapy (up to three prior regimens)
3. Measurable progressive disease (RECIST) or progression based on non-measurable lesions and CA-125.
4. WHO performance status * 2.
5. Left ventricular ejection fraction (LVEF) * 50%
6. Hematology: WBC > 3.0 x 109/L; ANC * 1.5 x 109/L; Hb * 10.0 g/dL; Platelet count * 100 x 109/L
7. Blood chemistry: Normal total bilirubin; AST/ALT * 2.5 x ULN; serum creatinine < 1.5 x ULN; Alkaline Phosphatase < 5 x ULN
8. Negative serum pregnancy test
9. Sexually active female patients must either be surgically sterilized, post-menopausal or practicing adequate contraceptive methods

Exclusion Criteria

1. Patients with CA-125-only disease.
2. Unresolved bowel obstruction.
3. Prior administration of and/or known hypersensitivity to: epothilones, anthracyclines and/or pegylated liposomal doxorubicin.
4. Peripheral neuropathy > CTC grade 1.
5. Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
6. Presenting with leptomeningeal involvement.
7. Colostomy.
8. Underlying uncontrolled medical disease(s) including unstable cardiac or coronary artery disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Overall survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Progression Free Survival<br /><br>Objective response rate, duration of best overall response, time to<br /><br>progression, best overall response, safety and tolerability of patupilone,<br /><br>detailed cardiac safety surveillance in a limited number patients, the<br /><br>pharmacokinetic relationship between patupilone exposure and adverse events in<br /><br>the study population, correlation between levels of betatubulin<br /><br>isoforms in tumor cells with resistance to patupilone, quality of life and<br /><br>change in disease symptoms</p><br>