A Phase II Trial of R435(Bevacizumab) in stage IVB, persistent or recurrent carcinoma of the cervix
Phase 2
- Conditions
- advanced or recurrent carcinoma of the cervix
- Registration Number
- JPRN-jRCT2080222700
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 6
Inclusion Criteria
Adult patients, >=20 years of age.
- GOG Performance Status of 0 or 1.
- Primary stage IVB, persistent or recurrent carcinoma of the cervix which is not amenable to curative treatment.
Exclusion Criteria
- Previously treated with chemotherapy except when used concurrently with radiation therapy.
- Serious non-healing wound, ulcer, or bone fracture. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months must pass before study entry.
- History or evidence upon physical examination of CNS disease.
- History of hemoptysis(>=Grade2) within 1 month before study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability<br>CTCAE ver4.03
- Secondary Outcome Measures
Name Time Method Safety, Efficacy<br>CTCAE ver4.03, RECIST ver1.1