Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)
NCT00862836 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2016-10-10
Summary
This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.
Conditions
Interventions
- DRUG
-
Vandetanib
100mg doses orally, once daily
Sponsors & Collaborators
-
Genzyme, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2010-09-30
- Completion
- 2010-09-30
Countries
- Germany
Study Locations
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