Apatinib and Etoposide Capsule Versus Weekly Paclitaxel in Patients With Platinum Resistant Ovarian Cancer
NCT ID: NCT04000295
Last Updated: 2019-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2019-08-16
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apatinib and Etoposide capsule
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
Etoposide
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
Weekly Paclitaxel
Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity
Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Interventions
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Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
Etoposide
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Eligibility Criteria
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Inclusion Criteria
2. Epithelial ovarian, fallopian tube or primary peritoneal cancer
3. Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy)
4. EOCG performance status of 0-1
Exclusion Criteria
2. Known hypersensitivity to any of the study drugs or excipients.
3. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
4. Congenital or acquired immune deficiency (e.g. HIV infected)
18 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Xin Huang, professor
Role: primary
Chunyan Lan, professor
Role: backup
Other Identifiers
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Ahead-OC-301
Identifier Type: -
Identifier Source: org_study_id
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