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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01802749
Other study ID # MITO-16 -MANGO-OV2b
Secondary ID 2012-004362-17EN
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 2013
Est. completion date December 2023

Study information

Verified date March 2023
Source National Cancer Institute, Naples
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab. Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined. This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.


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Study Design


Intervention

Drug:
Bevacizumab

Paclitaxel

Carboplatin

pegylated liposomal doxorubicin

Gemcitabine


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Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute, Naples Mario Negri Institute for Pharmacological Research

Countries where clinical trial is conducted

France,  Greece,  Italy,  Monaco,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other predictive clinical factors for efficacy of bevacizumab 12 months
Other correlation of baseline plasma biomarker expression and clinical outcome 12 months
Primary progression free survival assessed by local Investigator 12 months
Secondary overall survival 12 months
Secondary number of complete or partial responses according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 6 months
Secondary worst grade toxicity per patient according to Common Toxicity Criteria for Adverse Events v. 4.03 evaluated every 3 weeks up to 12 months
Secondary number of patients taking oral antidiabetic therapy at baseline
Secondary number of patients taking antithrombotic therapy at baseline
Secondary progression free survival as measured by independent central review 12 months
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