UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026475 |
|---|---|
| Receipt number | 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 | 2024/04/05 19:41:26 |
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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
| Obstetrics 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
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
nrg-japan@kuhs.ac.jp
Sponsor or person
Institute
NRG Oncology Group
Institute
Department
Personal name
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
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
https://www.ctsu.org/Public/Default.aspx?ReturnUrl=%2f
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ctsu.org/Public/Default.aspx?ReturnUrl=%2f
Number of participants that the trial has enrolled
578
Results
Unpublished
Results date posted
| 2022 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
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
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029143
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