- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884360
D9319C00001- 1L OC Mono Global RCT (MONO-OLA1)
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants With BRCA Wild Type Advanced High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based Chemotherapy (MONO-OLA1)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Santiago, Chile, 8241479
- Active, not recruiting
- Research Site
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Santiago, Chile, 8420383
- Active, not recruiting
- Research Site
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Temuco, Chile, 4810218
- Active, not recruiting
- Research Site
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Temuco, Chile, 4800827
- Active, not recruiting
- Research Site
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Viña del Mar, Chile, 2540488
- Terminated
- Research Site
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Baoji, China, 721008
- Active, not recruiting
- Research Site
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Beijing, China, 100142
- Recruiting
- Research Site
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Beijing, China, 100034
- Terminated
- Research Site
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Changchun, China, 130021
- Recruiting
- Research Site
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Changsha, China, 410013
- Recruiting
- Research Site
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Chengdu, China, 610041
- Recruiting
- Research Site
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Chengdu, China, 610072
- Active, not recruiting
- Research Site
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Chongqing, China, 400038
- Active, not recruiting
- Research Site
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Chongqing, China, 400042
- Active, not recruiting
- Research Site
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Guangzhou, China, 510120
- Completed
- Research Site
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Guangzhou, China, 510095
- Active, not recruiting
- Research Site
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Guiyang, China, 550004
- Active, not recruiting
- Research Site
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Haikou, China, 570312
- Withdrawn
- Research Site
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Haikou, China, 570311
- Active, not recruiting
- Research Site
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Hangzhou, China, 310006
- Withdrawn
- Research Site
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Hangzhou, China, 310022
- Recruiting
- Research Site
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Hefei, China, 230601
- Recruiting
- Research Site
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Hefei, China, 230001
- Recruiting
- Research Site
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Jiaxing, China, 314001
- Recruiting
- Research Site
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Jinan, China, 250117
- Withdrawn
- Research Site
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Jining, China, 272029
- Recruiting
- Research Site
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Lanzhou, China, 730030
- Withdrawn
- Research Site
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Lanzhou, China, 730030
- Active, not recruiting
- Research Site
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Linyi, China, 276000
- Recruiting
- Research Site
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Nanjing, China, 210009
- Recruiting
- Research Site
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Qingdao, China, 266034
- Recruiting
- Research Site
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Qingdao, China, 266103
- Withdrawn
- Research Site
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Rui'an, China, 325200
- Terminated
- Research Site
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Shanghai, China, 200032
- Recruiting
- Research Site
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Shanghai, China, 200011
- Recruiting
- Research Site
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Shengyang, China, 110004
- Withdrawn
- Research Site
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Shenyang, China, 110042
- Recruiting
- Research Site
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Shijiazhuang, China, 050000
- Withdrawn
- Research Site
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Suzhou, China, 215004
- Recruiting
- Research Site
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Tianjin, China, 300060
- Recruiting
- Research Site
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Tianjin, China, 300052
- Recruiting
- Research Site
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Urumqi, China, 830000
- Active, not recruiting
- Research Site
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Urumqi, China
- Completed
- Research Site
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Wenzhou, China, 325027
- Recruiting
- Research Site
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Wenzhou, China, CN-325000
- Recruiting
- Research Site
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Wuhan, China, 430022
- Recruiting
- Research Site
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Wuhan, China, 430000
- Recruiting
- Research Site
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Wuhan, China, 430022
- Active, not recruiting
- Research Site
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Wuxi, China, 214062
- Recruiting
- Research Site
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Xi'an, China, 710000
- Recruiting
- Research Site
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Xiamen, China, 361004
- Withdrawn
- Research Site
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Xianyang, China, 712000
- Withdrawn
- Research Site
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Xuzhou, China, 221000
- Active, not recruiting
- Research Site
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Xuzhou, China, 221009
- Active, not recruiting
- Research Site
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Yanji, China, 133000
- Recruiting
- Research Site
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Zibo, China, 255200
- Terminated
- Research Site
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Zunyi, China, 563100
- Active, not recruiting
- Research Site
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Barranquilla, Colombia, 80020
- Withdrawn
- Research Site
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Bogota, Colombia, 111321
- Withdrawn
- Research Site
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Bogota D.C., Colombia, 110131
- Withdrawn
- Research Site
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Bogotá, Colombia, 110221
- Active, not recruiting
- Research Site
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Bogotá, Colombia
- Active, not recruiting
- Research Site
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Ibague, Colombia, 730006
- Withdrawn
- Research Site
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Medellin, Colombia, 50030
- Active, not recruiting
- Research Site
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Medellín, Colombia, 50025
- Withdrawn
- Research Site
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Gurgaon, India, 122001
- Active, not recruiting
- Research Site
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Jaipur, India, 302017
- Active, not recruiting
- Research Site
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Kolkata, India, 700160
- Active, not recruiting
- Research Site
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Kolkata, India, 700026
- Withdrawn
- Research Site
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Madurai, India, 625107
- Active, not recruiting
- Research Site
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Namakkal, India, 637001
- Active, not recruiting
- Research Site
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Nashik, India, 422002
- Active, not recruiting
- Research Site
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New Delhi, India, 11029
- Active, not recruiting
- Research Site
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New Delhi, India, 110085
- Completed
- Research Site
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Arequipa, Peru, AREQUIPA01
- Active, not recruiting
- Research Site
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Lima, Peru, LIMA 34
- Active, not recruiting
- Research Site
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Lima, Peru, 15036
- Active, not recruiting
- Research Site
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Lima, Peru, LIMA 29
- Active, not recruiting
- Research Site
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San Isidro, Peru, 27
- Active, not recruiting
- Research Site
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Cebu, Philippines, 6000
- Withdrawn
- Research Site
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Quezon City, Philippines, 1112
- Withdrawn
- Research Site
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West San Juan City, Philippines, 1502
- Withdrawn
- Research Site
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Gdynia, Poland, 81-519
- Withdrawn
- Research Site
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Gliwice, Poland, 44-102
- Withdrawn
- Research Site
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Grzepnica, Poland, 72-003
- Withdrawn
- Research Site
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Poznań, Poland, 61- 848
- Withdrawn
- Research Site
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Szczecin, Poland, 70-111
- Withdrawn
- Research Site
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Arkhangelsk, Russian Federation, 163045
- Terminated
- Research Site
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Chelyabinsk, Russian Federation, 454087
- Active, not recruiting
- Research Site
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Ekaterinburg, Russian Federation, 620905
- Active, not recruiting
- Research Site
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Moscow, Russian Federation, 115478
- Active, not recruiting
- Research Site
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Moscow, Russian Federation, 117997
- Active, not recruiting
- Research Site
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Moscow, Russian Federation, 111123
- Withdrawn
- Research Site
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Nizhniy Novgorod, Russian Federation, 603089
- Withdrawn
- Research Site
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Obninsk, Russian Federation, 249036
- Withdrawn
- Research Site
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Saint Petersburg, Russian Federation, 197758
- Active, not recruiting
- Research Site
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Saint-Petersburg, Russian Federation, 198255
- Completed
- Research Site
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Sankt-Peterburg, Russian Federation, 197758
- Withdrawn
- Research Site
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St Petersburg, Russian Federation, 197341
- Withdrawn
- Research Site
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Tomsk, Russian Federation, 634028
- Active, not recruiting
- Research Site
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Cape Town, South Africa, 7570
- Withdrawn
- Research Site
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Johannesburg, South Africa, 2196
- Withdrawn
- Research Site
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Parktown, South Africa, 2193
- Withdrawn
- Research Site
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Port Elizabeth, South Africa, 6045
- Terminated
- Research Site
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Rondebosch, South Africa, 7700
- Withdrawn
- Research Site
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Adana, Turkey, 01120
- Active, not recruiting
- Research Site
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Ankara, Turkey, 06100
- Active, not recruiting
- Research Site
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Ankara, Turkey, 06800
- Active, not recruiting
- Research Site
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Istanbul, Turkey, 34010
- Active, not recruiting
- Research Site
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Karsiyaka, Turkey, 35575
- Active, not recruiting
- Research Site
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Samsun, Turkey, 55139
- Active, not recruiting
- Research Site
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Chernihiv, Ukraine, 14029
- Active, not recruiting
- Research Site
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Dnipro, Ukraine, 49102
- Completed
- Research Site
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Ivano-Frankivsk, Ukraine, 76018
- Active, not recruiting
- Research Site
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Kharkiv, Ukraine, 61103
- Active, not recruiting
- Research Site
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Kryvyi Rih, Ukraine, 50048
- Active, not recruiting
- Research Site
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Kyiv, Ukraine, 03022
- Active, not recruiting
- Research Site
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Kyiv, Ukraine, 04050
- Completed
- Research Site
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Zaporizhzhia, Ukraine
- Completed
- Research Site
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Ha noi, Vietnam, 100000
- Active, not recruiting
- Research Site
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Hanoi, Vietnam, 100000
- Active, not recruiting
- Research Site
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Ho Chi Minh, Vietnam, 700000
- Active, not recruiting
- Research Site
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Ho Chi Minh city, Vietnam
- Active, not recruiting
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
1,Participants must be ≥18 years at the time of (pre-)screening
2,Histological and staging criteria:Female participants who must have histologically newly diagnosed high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to the International FIGO 2009.
3, Participants are eligible if they fulfil any of the following surgical criteria:
- Stage III: primary debulking surgery with macroscopic residual disease post-surgery, neoadjuvant chemotherapy, or inoperable.
Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant chemotherapy, or inoperable.
4, Chemotherapy criteria:
- Participants must have received platinum-based chemotherapy consisting of a minimum of 6 treatment cycles and a maximum of 9, however, if platinum-based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, participants must have received a minimum of 4 cycles of the platinum regimen.
- Participants must have, in the opinion of the investigator, clinical CR or PR as per RECIST 1.1 criteria with no measurable lesion > 2 cm on the post-treatment scan and have no clinical evidence of disease progression or a rising CA-125 level (see inclusion criterion 5), following completion of this chemotherapy course.
A participant who received interval debulking surgery must have had ≥ 2 postoperative cycles of platinum-based therapy.
5, Participants must meet one of the criteria specified below for pre-treatment CA-125 measurements as follows:
- CA-125 in the normal range or
CA-125 decrease by ≥ 90% during their front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir. If the first value is greater than the upper limit of normal (ULN), a second assessment must be performed at least 7 days after the first. If the second assessment is > 15% more than the first value, the participant is not eligible).
6, Participants should not have received bevacizumab with first-line chemotherapy or be planned to receive bevacizumab maintenance therapy.
7, ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
8, Provision, at pre-screening, of a formalin-fixed, paraffin-embedded (FFPE) tumour sample to assess tBRCA status and for HRD testing centrally. The centrally performed tBRCA test results must be available prior to randomisation and must indicate that the participant has a BRCAwt tumour, defined by the absence of a deleterious or suspected deleterious BRCA mutation by central testing.
9, Adequate organ and marrow function.
Key Exclusion Criteria:
1, Participants with stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the participant's first-line chemotherapy treatment, or any evidence of progressive disease prior to randomization.
2, Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, undifferentiated ovarian cancer, non-epithelial ovarian cancer, borderline tumours or low grade epithelial ovarian tumours (applies to fallopian tube and primary peritoneal tumours where applicable).
3, Participants with Stage III disease who have had complete cytoreduction (ie, no macroscopic residual disease) at their primary debulking surgery.
4, Participants who have undergone ˃ 2 debulking (cytoreductive) surgeries.
5, History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention including adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, Grade 1 endometrial carcinoma. Participants with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the participant remains free of recurrent or metastatic disease.
6, Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included after consultation with the AstraZeneca study physician.
7, Participant is immunocompromised
8, Prior exposure to a PARP inhibitor, including olaparib
9, Any concurrent anticancer treatment
10, Currently pregnant or breast-feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Olaparib tablets 300 mg oral twice daily (n=280).
Participants in Group A will receive olaparib tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator's opinion they are benefiting from treatment and do not meet any other discontinuation criteria.
|
Olaparib tablets 300 mg oral twice daily
|
Placebo Comparator: Group B: Placebo tablets 300 mg oral twice daily (n=140)
Participants in Group B will receive matching placebo tablets taken orally at a dose of 300 mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator, whichever is earlier, and as long as in the investigator's opinion they are benefiting from treatment and do not meet any other discontinuation criteria.
|
Matching placebo tablets taken orally at a dose of 300 mg twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment.
Time Frame: Approximately 3 years
|
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
|
Approximately 3 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt tumour and a CR/PR following standard 1st line platinum-based chemotherapy treatment.
Time Frame: Approximately 3 years
|
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
|
Approximately 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of OS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard first line platinum based chemotherapy treatment.
Time Frame: Approximately 4 years
|
OS is defined as time from randomisation until the date of death due to any cause.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of OS in participants with Stage III/IV ovarian cancer with a BRCAwt tumour and a CR/PR following standard first-line platinum-based chemotherapy treatment.
Time Frame: Approximately 4 years
|
OS is defined as time from randomisation until the date of death due to any cause.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of TFST in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum-based chemotherapy treatment.
Time Frame: Approximately 4 years
|
TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of TFST in participants with a BRCAwt tumour and a CR or PR following standard first line platinum based chemotherapy treatment.
Time Frame: Approximately 4 years
|
TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS2 in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.
Time Frame: Approximately 4 years
|
PFS2 is defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS2 in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.
Time Frame: Approximately 4 years
|
PFS2 is defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of TSST in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.
Time Frame: Approximately 4 years
|
TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of TSST in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.
Time Frame: Approximately 4 years
|
TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause.
|
Approximately 4 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of time to TDT in participants with a BRCAwt HRD positive tumour and a CR/PR following standard first-line platinum based chemotherapy treatment.
Time Frame: Approximately 3 years
|
TDT is defined as time from randomisation until discontinuation of treatment for any reason, including disease progression, toxicity and death.
|
Approximately 3 years
|
To demonstrate superiority of olaparib as maintenance treatment relative to placebo by assessment of time to TDT in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment.
Time Frame: Approximately 3 years
|
TDT is defined as time from randomisation until discontinuation of treatment for any reason, including disease progression, toxicity and death.
|
Approximately 3 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of time to earliest progression by RECIST 1.1/CA 125/death in participants with a BRCAwt HRD positive tumour and a CR/PR following 1st line platinum based chemotherapy
Time Frame: Approximately 3 years
|
Time to earliest progression by RECIST 1.1/CA 125 or death will be measured from time of randomisation to the earlier date of RECIST 1.1/CA-125 progression or death by any cause.
|
Approximately 3 years
|
Superiority of olaparib as maintenance treatment relative to placebo by assessment of time to earliest progression by RECIST 1.1/CA 125/death in participants with a BRCAwt tumour and a CR/PR following first-line platinum based chemotherapy.
Time Frame: Approximately 3 years
|
Time to earliest progression by RECIST 1.1 or CA 125 or death will be measured from time of randomisation to the earlier date of RECIST 1.1 or CA-125 progression or death by any cause.
|
Approximately 3 years
|
Assess Health-related quality of life in participants treated with olaparib compared with placebo in participants with a BRCAwt HRD positive tumour and a CR or PR following standard first-line platinum based chemotherapy treatment
Time Frame: Approximately 3 years
|
Change from baseline in EORTC QLQ C30.
|
Approximately 3 years
|
Assess Health-related quality of life in participants treated with olaparib compared with placebo in participants with BRCAwt tumour and a CR or PR following standard first-line platinum based chemotherapy treatment
Time Frame: Approximately 3 years
|
Change from baseline in EORTC QLQ C30.
|
Approximately 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the safety and tolerability of olaparib in terms of AEs/SAEs as compared with placebo in participants with a BRCAwt tumour and a CR or PR following standard first-line platinum-based chemotherapy treatment.
Time Frame: Approximately 3 years
|
Graded according to the National Cancer Institute (NCI CTCAE)
|
Approximately 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaohua Wu, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Poly(ADP-ribose) Polymerase Inhibitors
- Olaparib
Other Study ID Numbers
- D9319C00001
- 2020-005960-68 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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CSPC Ouyi Pharmaceutical Co., Ltd.CompletedHealthy ParticipantsChina
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Dana-Farber Cancer InstituteNovartis; AstraZenecaCompleted
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Nordic Society of Gynaecological Oncology - Clinical...Hellenic Cooperative Oncology Group; European Network of Gynaecological Oncological... and other collaboratorsRecruiting
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AstraZenecaEuropean Network of Gynaecological Oncological Trial Groups (ENGOT)CompletedEpithelial Ovarian CancerDenmark, France, Germany, Italy, Spain, Poland, Belgium, Canada, United Kingdom, Israel, Norway
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AstraZenecaMerck Sharp & Dohme LLC; European Network of Gynaecological Oncological Trial... and other collaboratorsActive, not recruitingRelapsed Ovarian Cancer | Following Complete or Partial Response to Platinum Based Chemotherapy | Platinum Sensitive | BRCA MutatedKorea, Republic of, France, China, Italy, United States, Israel, United Kingdom, Canada, Japan, Germany, Brazil, Netherlands, Belgium, Poland, Australia, Russian Federation, Spain
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SandozCompleted
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Qilu Pharmaceutical Co., Ltd.Completed
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Leiden University Medical CenterUniversity Medical Center Groningen; Erasmus Medical CenterRecruitingBRCA1 Mutation | BRCA2 Mutation | Homologous Recombination Deficiency | Ovarian Neoplasm EpithelialNetherlands