UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019560 |
|---|---|
| Receipt number | R000022619 |
| Scientific Title | Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2024/03/06 17:46:46 |
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Basic information
Public title
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance
Acronym
Randomized, Double-Blind Controll Trial of Olaparib vs. Placebo in Patients with Advanced Ovarian Cancer (PAOLA-1)
Scientific Title
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance
Scientific Title:Acronym
Randomized, Double-Blind Controll Trial of Olaparib vs. Placebo in Patients with Advanced Ovarian Cancer (PAOLA-1)
Region
| Japan | Europe |
Condition
Condition
Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian,Fallopian Tube, or Peritoneal Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine the efficacy by progression free survival (PFS1) investigator based according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of olaparib
maintenance compared to placebo in high grade epithelial ovarian, fallopian tube, or peritoneal cancer that are in clinical complete response or partial response following first line platinumtaxane based chemotherapy plus bevacizumab, and planned to pursue bevacizumab in the maintenance phase up to a total of 15 months.
Basic objectives2
Others
Basic objectives -Others
1. To determine :
#1 time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death
#2 time from randomization to first subsequent therapy or death (TFST)
#3 time from randomization to second progression (PFS2)
#4 time from randomization to second subsequent therapy or death (TSST)
#5 overall survival (OS)
2. To assess the safety and tolerability of olaparib maintenance compared to placebo.
3. To compare the effects of olaparib maintenance compared to placebo on
Health-Related Quality of Life (HRQoL) and patient reported outcomes (PROs), with
consideration of patient preference.
4. To evaluate the impact of treatment and disease on resource use.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
The primary endpoint is progression-free survival (PFS1) defined as the time from the date of
randomization to the first documented disease progression (according to RECIST v1.1) or death
from any cause, whichever occurs first.
Key secondary outcomes
1. To determine :
#1 time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death
#2 time from randomization to first subsequent therapy or death (TFST)
#3 time from randomization to second progression (PFS2)
#4 time from randomization to second subsequent therapy or death (TSST)
#5 overall survival (OS)
2. To assess the safety and tolerability of olaparib maintenance compared to placebo.
3. To compare the effects of olaparib maintenance compared to placebo on
Health-Related Quality of Life (HRQoL) and patient reported outcomes (PROs), with
consideration of patient preference.
4. To evaluate the impact of treatment and disease on resource use.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
Olaparib tablets per os 300 mg twice daily
Interventions/Control_2
Placebo tablets per os 300 mg twice daily
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Signed informed consent and ability to comply with treatment and follow-up.
2. Patient with newly diagnosed, Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer, Histologically confirmed high grade serous or high grade endometrioid or other epithelial non mucinous ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation, at an advanced stage: FIGO stage IIIB, IIIC, or IV of the 1988 FIGO classification.
3. Patient who has completed prior to randomization first line platinum-taxane chemotherapy.
4. Patient must have received prior to randomization a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of platinum-based chemotherapy. Bevacizumab treatment should be administered at a dose 15mg/kg q3 weeks up to a total of 15 months.
5. Patient must be prior to randomization without NED or in CR or PR from her first line treatment. There should be no clinical evidence of disease progression throughout her first line treatment and prior to study randomization.
6. Patient must be randomized at least 3 weeks and no more than 9 weeks after her last dose of chemotherapy (last dose is the day of the last infusion) and all major toxicities from the previous chemotherapy must have resolved to CTC AE grade 1 or better.
7. Patient must have normal organ and bone marrow function.
8. ECOG performance status 0-1.
9. Formalin fixed, paraffin embedded tumor sample from the primary cancer must be available for central BRCA testing and test result must be available for stratification.
10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment.
Key exclusion criteria
1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum
2. Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
3. Patient with synchronous primary endometrial cancer unless both of the following criteria are met: stage < II, Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR over 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma.
4. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided she completed her adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease. Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment.
5. Patient with myelodysplastic syndrome/acute myeloid leukemia history.
6. Patient having experienced for at least one cycle, a delay > 2 weeks due to prolonged hematological recovery during the first line chemotherapy.
7. Patient receiving radiotherapy within 6 weeks prior to study treatment.
8. Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery.
9. Previous allergenic bone marrow transplant.
10. Any previous treatment with PARP inhibitor, including olaparib. et cetera
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Isabelle |
| Middle name | |
| Last name | Ray-Coquard |
Organization
Centre Leon Berard
Division name
ARCAGY Research
Zip code
69008
Address
28, rue Laennec, 69373 Lyon Cedex 08-FRANCE
TEL
+33(0)478782828
isabelle.ray-coquard@lyon.unicancer.fr
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Fujiwara |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gynecologic Oncology
Zip code
350-1241
Address
1397-1, Yamane, Hidaka-City, Saitama
TEL
042-984-4111
Homepage URL
paola@kuhs.ac.jp
Sponsor or person
Institute
GOTIC
Institute
Department
Personal name
Funding Source
Organization
ARCAGY-Research
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
France
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka-City, Saitama
Tel
042-984-4111
chikens@saitama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
EudraCT No; 2014-004027-52
Org. issuing International ID_1
EMA
Study ID_2
ENGOT-ov25
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学国際医療センター、自治医科大学附属病院、筑波大学附属病院、国立がん研究センター中央病院、兵庫県立がんセンター、愛媛大学医学部附属病院、鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022619
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