Phase
Condition
Ovarian Cancer
Fallopian Tube Cancer
Pelvic Cancer
Treatment
Acetaminophen (or equivalent)
Dexamethasone (or equivalent)
Bevacizumab
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has histologically confirmed epithelial ovarian, fallopian tube, or primaryperitoneal carcinoma.
Has received 4 or more cycles of platinum-based doublet chemotherapy in first-lineand a total of 6 cycles of carboplatin-based doublet chemotherapy in second-linesetting for ovarian cancer (OC).
Has platinum-sensitive epithelial OC,
Has provided tissue of a tumor lesion that was not previously irradiated
Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on antiretroviral therapy
Participants who are hepatitis B surface antigen positive are eligible if they havereceived hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and haveundetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening
Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
Exclusion
Exclusion Criteria:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderlinetumors (low malignant potential), mucinous, seromucinous that is predominantlymucinous, malignant Brenner's tumor and undifferentiated carcinoma
Has platinum-resistant OC or platinum-refractory OC
Has history of documented severe dry eye syndrome, severe Meibomian gland diseaseand/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication orprevious history of inflammatory bowel disease (e.g. Crohn's disease, ulcerativecolitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease
Has received more than 2 prior lines of systemic therapy for OC.
Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
Has received prior radiotherapy within 2 weeks of allocation (Part 1) orrandomization (Part 2), or has radiation related toxicities, requiringcorticosteroids
Has an additional malignancy that is progressing or has required active treatmentwithin the past 3 years
Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
Study Design
Connect with a study center
Gallipoli Medical Research Ltd ( Site 0214)
Brisbane, Queensland 4120
AustraliaActive - Recruiting
Epworth Freemasons ( Site 0217)
East Melbourne, Victoria 3002
AustraliaActive - Recruiting
Kurume University Hospital ( Site 1640)
Kurume, Fukuoka 830-0011
JapanActive - Recruiting
Saitama Medical University International Medical Center ( Site 1632)
Hidaka, Saitama 350-1298
JapanActive - Recruiting
Cancer Institute Hospital of JFCR ( Site 1639)
Koto, Tokyo 135-8550
JapanActive - Recruiting
Niigata Cancer Center Hospital ( Site 1633)
Niigata, 951-8566
JapanActive - Recruiting
National Cancer Center ( Site 2305)
Goyang-si, Kyonggi-do 10408
Korea, Republic ofActive - Recruiting
Severance Hospital ( Site 2302)
Seodaemun-Gu, Seoul 03722
Korea, Republic ofActive - Recruiting
Asan Medical Center ( Site 2304)
Songpa-gu, Seoul 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center ( Site 2303)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital ( Site 2301)
Seoul, 03080
Korea, Republic ofActive - Recruiting
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
Girona, Gerona 17007
SpainActive - Recruiting
Clinica Universidad de Navarra ( Site 2407)
Madrid, Madrid, Comunidad De 28027
SpainActive - Recruiting
Hospital Vall D Hebron ( Site 2403)
Barcelona, 08035
SpainActive - Recruiting
ICO L Hospitalet ( Site 2408)
Barcelona, 08907
SpainActive - Recruiting
Hospital Universitario Reina Sofia ( Site 2406)
Cordoba, 14004
SpainActive - Recruiting
Taichung Veterans General Hospital ( Site 2603)
Taichung, 40705
TaiwanActive - Recruiting
National Cheng Kung University Hospital ( Site 2602)
Tainan, 704
TaiwanActive - Recruiting
Mackay Memorial Hospital ( Site 2604)
Taipei, 104
TaiwanActive - Recruiting
Sarasota Memorial Hospital ( Site 0075)
Sarasota, Florida 34239
United StatesActive - Recruiting
St. Dominic's Hospital ( Site 0064)
Jackson, Mississippi 39216
United StatesActive - Recruiting
Nebraska Methodist Hospital ( Site 0053)
Omaha, Nebraska 68114
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0071)
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
University of Cincinnati Medical Center ( Site 0090)
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)
Tulsa, Oklahoma 74146
United StatesActive - Recruiting
Women & Infants Hospital ( Site 0050)
Providence, Rhode Island 02905
United StatesActive - Recruiting
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