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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026475
Receipt No. R000029143
Scientific Title A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer
Date of disclosure of the study information 2017/03/09
Last modified on 2019/07/01

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Basic information
Public title A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer
Acronym NRG-GY004
Scientific Title A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer
Scientific Title:Acronym NRG-GY004
Region
Japan Asia(except Japan) North America
Europe

Condition
Condition platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum- sensitive ovarian, primary peritoneal or fallopian tube cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum- sensitive ovarian, primary peritoneal or fallopian tube cancer.
Key secondary outcomes Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate, and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm I(Reference Regimen): Platinum-based chemotherapy
Interventions/Control_2 Arm II:Olaparib monotherapy
Interventions/Control_3 Arm III:Olaparib and cediranib
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers.
Patients must have evaluable disease-defined as one of the following:
RECIST 1.1 measurable disease OR Evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related) AND CA125 that has doubled from the post-treatment nadir and is also greater than 2 times ULN.
Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy.
Patients may have received an unlimited number of platinum-based therapies in the recurrent setting.
Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting. Prior hormonal therapy will not be considered to count as this non-platinum-based line.
Patients may not have had a prior anti-angiogenic agent in the recurrent setting. Prior use of bevacizumab in the upfront or upfront maintenance setting is allowed.
Patients may not have previously received a PARP-inhibitor.
Prior hormonal-based therapy for ovarian, primary peritoneal,or fallopian tube cancer is acceptable.
Patients must have an ECOG Performance Status of 0, 1 or 2
Patients must have adequate organ and marrow function.
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to Grade 1 as per NCI-CTCAE v4.0.
Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses.
Patients must have adequately controlled blood pressure.
Patients must be willing and able to check and record daily blood pressure readings.
Women of child-bearing potential must have a negative pregnancy test prior to study entry.
Adequately controlled thyroid function.
Key exclusion criteria Patients who have had chemotherapy or radiotherapy within 4 weeks of starting treatment prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, or had hormonal therapy within 2 weeks prior to entering the study.
Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks, nor receiving any medication that may markedly affect renal function, nor have received prior treatment affecting the VEGF pathway, nor have previously received a PARP inhibitor.
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib.
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible.
History of gastrointestinal perforation.
History of intra-abdominal abscess within the past 3 months.
Current signs and/or symptoms of bowel obstruction or signs.
Dependency on IV hydration or TPN.
Any concomitant or prior invasive malignancies with the following curatively treated exceptions.
History of myocardial infarction within six months,Unstable angina,Resting ECG with clinically significant abnormal findings,NYHA classification of III or IV.
History of stroke or transient ischemic attack within six months.
Any prior history of hypertensive crisis or hypertensive encephalopathy.
Clinically significant peripheral vascular disease or vascular disease.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib.
Uncontrolled intercurrent illness.
Pregnant women
Known HIV-positive individuals.
No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation.
Target sample size 561

Research contact person
Name of lead principal investigator
1st name JOYCE
Middle name
Last name LIU
Organization DANA-FARBER CANCER INSTITUTE
Division name Department of NRG Oncology
Zip code 02215
Address 450 BROOKLINE AVENUE BOSTON, MA 02215
TEL 617-632-8927
Email joyce_liu@dfci.harvard.edu

Public contact
Name of contact person
1st name Keiichi
Middle name
Last name Fujiwara, MD.,PhD
Organization Saitama Medical University International Medical Center
Division name Department of Gynecologic Oncology
Zip code 350-1298
Address 1397-1, Yamane, HIdaka-city, Saitama
TEL 042-984-4111
Homepage URL
Email nrg-japan@newkast.or.jp

Sponsor
Institute NRG Oncology Group
Institute
Department

Funding Source
Organization NRG Oncology Group
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Med U International Med Ctr IRB
Address 1397-1 Yamane, Hidaka-city, Saitama
Tel 042-984-4523
Email chikens@saitama-med.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02446600
Org. issuing International ID_1 National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学国際医療センター(埼玉県)、岩手医科大学附属病院(岩手県)、国立がん研究センター中央病院(東京都)、鹿児島市立病院(鹿児島県)、がん研究会有明病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 578
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 02 Month 04 Day
Date of IRB
2017 Year 01 Month 18 Day
Anticipated trial start date
2017 Year 08 Month 03 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 09 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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