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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004456-30 | EudraCT Number | ||
| B9991030 | Other Identifier | Alias Study Number | |
| JAVELIN OVARIAN PARP 100 | Other Identifier | Alias Study Number |
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Phase 3 B9991010 study was stopped due to futility of efficacy at interim analysis on 21Dec2018, and approvals of PARP inhibitors in front-line maintenance setting, Pfizer decided stopping enrollment in the B9991030 study on 19Mar2019.
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JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.
JAVELIN Ovarian PARP 100 (B9991030) is an open-label, international, multi-center, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The primary endpoint is progression-free survival (PFS) as determined based on blinded independent central review (BICR) assessment per RECIST v1.1.
On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study. The alliance has notified health authorities and trial investigators of the decision to discontinue the trial. The decision was based on several emerging factors since the trial's initiation, including the previously announced interim results from JAVELIN Ovarian 100 study (B9991010), which was stopped due to futility of efficacy at a planned interim analysis on 21 December 2018. The alliance determined that the degree of benefit observed with avelumab in frontline ovarian cancer in that study does not support continuation of the JAVELIN Ovarian PARP 100 trial in an unselected patient population and emphasizes the need to better understand the role of immunotherapy in ovarian cancer. Additional factors include the rapidly changing treatment landscape and the approval of a PARP inhibitor in the frontline maintenance setting. The decision to discontinue the JAVELIN Ovarian PARP 100 trial was not made for safety reasons.
Patients who remain in the study will continue receiving investigational products according to their randomized treatment assignment and will be monitored for appropriate safety assessments until treatment discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy, avelumab and talazoparib | Experimental | Platinum-based chemotherapy + avelumab followed by avelumab + talazoparib maintenance |
|
| chemotherapy, and talazoparib | Experimental | Platinum-based chemotherapy followed by talazoparib maintenance |
|
| chemotherapy and bevacizumab | Active Comparator | Platinum-based chemotherapy + bevacizumab followed by bevacizumab maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy + avelumab followed by avelumab + talazoparib | Drug | Chemotherapy Period Paclitaxel Carboplatin Avelumab Maintenance Period Avelumab Talazoparib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） | Progression-free survival (PFS) was defined as the time from randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. | At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (On-Treatment Period) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was lifethreatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event. AEs included SAEs and non-serious AEs. On-treatment period was defined as the time from the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day. |
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Inclusion Criteria:
Histologically confirmed Stage III IV epithelial ovarian, fallopian tube, or primary peritoneal cancer including carcinosarcoma with high-grade serous component.
Patients must be candidates for bevacizumab in combination with platinum based chemotherapy and previously untreated.
Must have completed a primary surgical debulking procedure, or be candidates for neoadjuvant chemotherapy with planned interval debulking surgery.
Patients who completed primary debulking must have had incompletely resected disease that is macroscopically/grossly visible and at least with lesions >1 mm and be randomized at a maximum of 8 weeks after surgery.
For patients who are candidates for neoadjuvant chemotherapy, the diagnoses must have been confirmed by:
Availability of an archival FFPE tumor tissue block or a minimum of 25 slides, together with an accompanying original H&E slide. If archived FFPE tissue is not available, a de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies. Tumor tissue must contain 40% or greater tumor nuclei per central laboratory assessment.
ECOG performance status 0-1
Age >=18 years (or >=20 years in Japan).
Adequate bone marrow, hepatic, and renal function and blood coagulation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | United States | ||
| Arizona Oncology Associates, PC - HAL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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As of 19 March 2019, the sponsor decided to stop enrollment/randomization in the study. A total of 104 participants were screened and 79 participants completed screening and randomized in the study before study discontinuation. As only 11% projected enrollment was met at the time of enrollment stop, the original study endpoints are no longer applicable and/or feasible; only the Safety, PK and Immunogenicity Analysis were done and these data are included in this report.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy +Avelumab -> Avelumab + Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 intravenously(IV) over 3 hours followed by carboplatin area under the concentration (AUC) 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles along with avelumab 800 mg administered IV on Day 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received avelumab 800 mg administered IV on Days 1, 15 and 29 of each 6-week cycle in combination with talazoparib 0.75 mg self-administered orally once per day. A cycle was defined as 3 weeks (21 days) in the chemotherapy period and 6 weeks (42 days) in the maintenance period, respectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Chemotherapy Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2019 | Dec 6, 2022 |
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| Chemotherapy followed by talazoparib maintenance | Drug | Chemotherapy Period Paclitaxel Carboplatin Maintenance Period Talazoparib |
|
| Chemotherapy + bevacizumab followed by bevacizumab | Drug | Chemotherapy Period Paclitaxel Carboplatin Bevacizumab Maintenance Period Bevacizumab |
|
| From the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day (maximum up to 3.5 years approximately) |
| Number of Participants With ADA Against Avelumab by Never and Ever Positive Status | Predose Anti-drug antibodies (ADA) samples were collected within 2 hours prior to avelumab dosing and drawn from the contralateral arm of the avelumab infusion. | Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months. |
| Pre-dose/Trough Concentration (Ctrough) for Avelumab (Chemotherapy Period) | Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data | Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks) |
| Pre-dose/Trough Concentration (Ctrough) for Avelumab (Maintenance Period) | Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data | Pre-dose on Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period (1 cycle = 6 weeks) and at the end of treatment, up to 27 months. |
| Cmax for Avelumab (Chemotherapy Period) | Cmax was defined as maximum observed plasma concentration and it was observed directly from data | Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks) |
| Cmax for Avelumab (Maintenance Period) | Cmax was defined as maximum observed plasma concentration and it was observed directly from data | Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months. |
| Ctrough for Talazoprib (Maintenance Period) | Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data. | Pre-dose on Days 1, 15 and 29 of Cycle 1 |
| Overall Survival (Participants of Both DDR+ and Unselected DDR Status) | OS was defined as the time from the date of randomization to the date of death due to any cause. | From 9 weeks up to approximately 3.5 years |
| Progression-free Survival (Participants of Unselected DDR Status) | PFS was defined as the time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occured first. | At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years. |
| Progression-free Survival (Participants of Both DDR+ and Unselected DDR Status) | PFS was defined as the time from randomization to the date of the first documentation of objective progressive disease(PD) or death due to any cause, whichever occured first. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method. | At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years. |
| Progression-free Survival on Next-line Therapy. (Participants of Both DDR+ and Unselected DDR Status) | Progression-free survival on next-line therapy (PFS2) was defined as time from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occured first. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method | From screening until the participant had objective PD on or prior to start of next-line anti-cancer treatment, and started a second subsequent anti-cancer treatment or the participant died, up to approximately 3.5 years. |
| PFS Per Gynecological Cancer Intergroup Criteria (Participants of Both DDR+ and Unselected DDR Status) | PFS based on investigator assessment per Gynecological Cancer Intergroup criteria (GCIG) would be assessed incorporating both Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and CA 125. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method. | From screening until death, end of study, or participant withdrawal of consent, whichever occurred first, up to approximately 3.5 years. |
| Functional Assessment of Ovarian Symptom Index-18 (FOSI-18) Score | NFOSI-18 was an ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. It was specifically designed to be a stand-alone instrument to measure disease-related symptoms, treatment side effects and function/well-being in participants with ovarian cancer. The NFOSI-18 has several subscales: disease-related symptoms physical subscale(9 items), disease-related symptoms emotional subscale(1 item), treatment-related side effect subscale (5 items) and functional well-being (3 items). A high score was good. A score of "0" was a severely symptomatic participant and the highest possible score was an asymptomatic participant. | 3 years |
| Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline | The number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest that were defined by tumor cell morphology and the presence or absence of inflammatory cells | Baseline |
| Number of Participants With Mutations in Key Oncogenes at Baseline | Determination/estimation of the frequency of mutations (total and non-synonymous) present in baseline tumor derived nucleic acid samples and in baseline circulating tumor DNA. | Baseline |
| EuroQol Group 5-Dimension 5-Level (EQ-5D-5L) Score | The EuroQol EQ-5D-5L was a 6 item participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights were available that allow for imputation of the index score. Overall index scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. | 3 years |
| Phoenix |
| Arizona |
| 85027 |
| United States |
| Arizona Oncology Associates, PC - HAL | Scottsdale | Arizona | 85258 | United States |
| Arizona Oncology Associates, PC - HAL | Tempe | Arizona | 85284 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85711 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Sansum Clinic | Solvang | California | 93463 | United States |
| Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06510 | United States |
| NYU Winthrop Hospital, Gynecologic Oncology | Mineola | New York | 11501 | United States |
| NYU Winthrop Hospital, Infusion Center | Mineola | New York | 11501 | United States |
| NYU Winthrop Radiology | Mineola | New York | 11501 | United States |
| Montefiore Medical Center - EPC | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center, Department of Obstetrics and Gynecology and Women's Health | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center-Centennial Facility | The Bronx | New York | 10467 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45211 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45230 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45236 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97213-2982 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97225 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | United States |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | United States |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | United States |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | United States |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | United States |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | United States |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | United States |
| Texas Oncology Bedford | Bedford | Texas | 76022 | United States |
| Texas Oncology | Fort Worth | Texas | 76104 | United States |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center | Irving | Texas | 75063 | United States |
| Texas Oncology- San Antonio | San Antonio | Texas | 78240 | United States |
| Virginia Oncology Associates | Chesapeake | Virginia | 23320 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | United States |
| Epworth Foundation trading as Epworth HealthCare | East Melbourne | Victoria | 3002 | Australia |
| Epworth HealthCare, Clinical Trials & Research Centre | Richmond | Victoria | 3121 | Australia |
| CHU-UCL Namur/Site Sainte Elisabeth | Namur | 5000 | Belgium |
| Bon Secours Hospital | Cork | T12 DV56 | Ireland |
| Istituto Europeo di Oncologia (IEO) | Milan | MI | 20141 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | RM | 00168 | Italy |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Limited Liability Company "VitaMed" (LLC "VitaMed") | Moscow | 121309 | Russia |
| Department of Nuclear Medicine and Molecular Imaging | Singapore | 169608 | Singapore |
| SingHealth Investigational Medicine Unit | Singapore | 169608 | Singapore |
| National Cancer Centre Singapore | Singapore | 169610 | Singapore |
| Department of Pathology | Singapore | 169856 | Singapore |
| Raffles Hospital | Singapore | 188770 | Singapore |
| Raffles Radiology | Singapore | 188770 | Singapore |
| Farrer Park Hospital | Singapore | 217562 | Singapore |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06229 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Clinical Trial Pharmacy, Samsung Medical Center | Seoul | 06351 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Department of Radiology, Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Division of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| FG001 | Chemotherapy -> Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| FG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
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| NOT COMPLETED |
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| Maintenance Period |
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| Follow-up Period |
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The baseline analysis population included all randomized participants who received at least 1 dose of study drug (avelumab, talazoparib, bevacizumab, carboplatin, paclitaxel).
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy +Avelumab -> Avelumab + Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 intravenously(IV) over 3 hours followed by carboplatin area under the concentration (AUC) 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles along with avelumab 800 mg administered IV on Day 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received avelumab 800 mg administered IV on Days 1, 15 and 29 of each 6-week cycle in combination with talazoparib 0.75 mg self-administered orally once per day. A cycle was defined as 3 weeks (21 days) in the chemotherapy period and 6 weeks (42 days) in the maintenance period, respectively. |
| BG001 | Chemotherapy -> Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| BG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (On-Treatment Period) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was lifethreatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event. AEs included SAEs and non-serious AEs. On-treatment period was defined as the time from the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day. | The safety analysis set included all randomized participants who received at least 1 dose of study drug (avelumab, talazoparib, bevacizumab, carboplatin, paclitaxel). Participants was classified according to the study treatment assigned at randomization unless the incorrect treatment(s) was/were received throughout the dosing period in which case participants would be classified according to the first study treatment received. | Posted | Count of Participants | Participants | From the first dose of study treatment through up to 30 days after minimum last dose of study treatment or start day of new anti-cancer drug therapy minus 1 day (maximum up to 3.5 years approximately) |
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| Secondary | Number of Participants With ADA Against Avelumab by Never and Ever Positive Status | Predose Anti-drug antibodies (ADA) samples were collected within 2 hours prior to avelumab dosing and drawn from the contralateral arm of the avelumab infusion. | The immunogenicity analysis set was a subset of the safety analysis set and included participants in Arm A (Chemotherapy +Avelumab -> Avelumab + Talazoparib) only, who had at least 1 ADA sample collected. Only avelumab containing arm (Arm A) was included as the analysis was against avelumab. | Posted | Count of Participants | Participants | Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months. |
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| Secondary | Pre-dose/Trough Concentration (Ctrough) for Avelumab (Chemotherapy Period) | Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data | The pharmacokinetic (PK) concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 concentration above the below limit of quantitation (BLQ) of either avelumab or talazoparib. Only avelumab containing arm (Arm A) was applicable as it was an analysis of avelumab concentration. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | mcg/mL | Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks) |
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| Secondary | Pre-dose/Trough Concentration (Ctrough) for Avelumab (Maintenance Period) | Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data | The pharmacokinetic (PK) concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 concentration above the below limit of quantitation (BLQ) of either avelumab or talazoparib. Only avelumab containing arm (Arm A) was applicable as it was an analysis of avelumab concentration. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | mcg/mL | Pre-dose on Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period (1 cycle = 6 weeks) and at the end of treatment, up to 27 months. |
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| Secondary | Cmax for Avelumab (Chemotherapy Period) | Cmax was defined as maximum observed plasma concentration and it was observed directly from data | The pharmacokinetic (PK) concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 concentration above the below limit of quantitation (BLQ) of either avelumab or talazoparib. Only avelumab containing arm (Arm A) was applicable as it was an analysis of avelumab concentration. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | mcg/mL | Day 1 of Cycles 1, 2, 3, and 4 in the chemotherapy period (1 cycle = 3 weeks) |
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| Secondary | Cmax for Avelumab (Maintenance Period) | Cmax was defined as maximum observed plasma concentration and it was observed directly from data | The pharmacokinetic (PK) concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 concentration above the below limit of quantitation (BLQ) of either avelumab or talazoparib. Only avelumab containing arm (Arm A) was applicable as it was an analysis of avelumab concentration. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | mcg/mL | Day 1 pre-dose of Cycles 1, 2, 3, and 4 in the chemotherapy period and Days 1 and 29 of Cycle 1 and Day 1 of Cycles 2, 4, 6, and 10 in the maintenance period and at the end of treatment/withdrawal, up to 27 months. |
| |||||||||||||||||||||||||||||||||
| Secondary | Ctrough for Talazoprib (Maintenance Period) | Ctrough was defined as predose concentration during multiple dosing and it was observed directly from data. | The pharmacokinetic (PK) concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 concentration above the lower limit of quantitation (LLQ) of either avelumab or talazoparib. Only the talazoprib containing arms (Arm A and Arm B) were applicable as it was an analysis of talazoprib concentration. It is anticipated the number of participants for PK concentration analysis set would be different from safety analysis set. | Posted | Median | Full Range | pg/mL | Pre-dose on Days 1, 15 and 29 of Cycle 1 |
| |||||||||||||||||||||||||||||||||
| Primary | Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） | Progression-free survival (PFS) was defined as the time from randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (Participants of Both DDR+ and Unselected DDR Status) | OS was defined as the time from the date of randomization to the date of death due to any cause. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | From 9 weeks up to approximately 3.5 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (Participants of Unselected DDR Status) | PFS was defined as the time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occured first. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (Participants of Both DDR+ and Unselected DDR Status) | PFS was defined as the time from randomization to the date of the first documentation of objective progressive disease(PD) or death due to any cause, whichever occured first. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by BICR regardless of initiation of new anti-cancer therapy, up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival on Next-line Therapy. (Participants of Both DDR+ and Unselected DDR Status) | Progression-free survival on next-line therapy (PFS2) was defined as time from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occured first. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | From screening until the participant had objective PD on or prior to start of next-line anti-cancer treatment, and started a second subsequent anti-cancer treatment or the participant died, up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PFS Per Gynecological Cancer Intergroup Criteria (Participants of Both DDR+ and Unselected DDR Status) | PFS based on investigator assessment per Gynecological Cancer Intergroup criteria (GCIG) would be assessed incorporating both Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and CA 125. Participants was defined as having defective DDR (DDR+) or having intact DDR (DDR ) using a next generation sequencing based assay method. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | From screening until death, end of study, or participant withdrawal of consent, whichever occurred first, up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Ovarian Symptom Index-18 (FOSI-18) Score | NFOSI-18 was an ovarian cancer-specific symptom index comprised of symptoms rated as highest priority by both oncology clinical experts and women with advanced ovarian cancer. It was specifically designed to be a stand-alone instrument to measure disease-related symptoms, treatment side effects and function/well-being in participants with ovarian cancer. The NFOSI-18 has several subscales: disease-related symptoms physical subscale(9 items), disease-related symptoms emotional subscale(1 item), treatment-related side effect subscale (5 items) and functional well-being (3 items). A high score was good. A score of "0" was a severely symptomatic participant and the highest possible score was an asymptomatic participant. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | 3 years |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor and Immune Cells as Assessed by Immunohistochemistry (IHC) at Baseline | The number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest that were defined by tumor cell morphology and the presence or absence of inflammatory cells | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | Baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Mutations in Key Oncogenes at Baseline | Determination/estimation of the frequency of mutations (total and non-synonymous) present in baseline tumor derived nucleic acid samples and in baseline circulating tumor DNA. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | Baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | EuroQol Group 5-Dimension 5-Level (EQ-5D-5L) Score | The EuroQol EQ-5D-5L was a 6 item participant-completed questionnaire designed to assess health status in terms of a single index value or utility score. There are 2 components to the EQ-5D-5L, a Health State Profile which had individuals rate their level of problems (none, slight, moderate, severe, extreme/unable) in 5 areas (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and a Visual Analogue Scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights were available that allow for imputation of the index score. Overall index scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. | This OM measure was planned but due to the premature termination of the study and consequent lack of meaningful data, data are not available and no analyses were performed. | Posted | 3 years |
|
All-Cause mortality: collected from the signing of Informed Consent (IC) up to 90 calendar days after the last administration of the investigational product (maximum of approximately 3.5 years). Serious and non-serious adverse events (AEs) were collected from the time of the first dose of study treatment through up to 30 days after last dose of study treatment or the start of new anti-cancer drug therapy minus 1 day (maximum of approximately 3.5 years).
Both non serious AEs and SAEs were recorded on the case report form.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy +Avelumab -> Avelumab + Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 intravenously(IV) over 3 hours followed by carboplatin area under the concentration (AUC) 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles along with avelumab 800 mg administered IV on Day 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received avelumab 800 mg administered IV on Days 1, 15 and 29 of each 6-week cycle in combination with talazoparib 0.75 mg self-administered orally once per day. A cycle was defined as 3 weeks (21 days) in the chemotherapy period and 6 weeks (42 days) in the maintenance period, respectively. | 1 | 29 | 9 | 29 | 29 | 29 |
| EG001 | Chemotherapy -> Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. | 0 | 13 | 4 | 13 | 13 | 13 |
| EG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. | 2 | 34 | 15 | 34 | 34 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood corticotrophin increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
As of 19 March 2019, the sponsor decided to stop enrollment/randomization in the study. A total of 104 participants were screened and 79 participants completed screening and randomized in the study before study discontinuation. As only 11% projected enrollment was met at the time of enrollment stop, the original study endpoints are no longer applicable and/or feasible; only the Safety, PK and Immunogenicity Analysis were done and these data are included in this report.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2018 | Dec 6, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C586365 | talazoparib |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
| Physician's decision |
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| Progressive disease |
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| Other |
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| Withdrawal by Subject |
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| Study terminated by sponsor |
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| Lack of Efficacy |
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| Death |
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| Adverse Event |
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| 65 =< 75 years |
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| 75 =< 85 years |
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| >= 85 years |
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| Not Reported |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
|
| Unknown |
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In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles.
In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle.
|
|
| OG001 | Chemotherapy -> Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| Chemotherapy -> Talazoparib |
In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles.
In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle.
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| OG001 | Chemotherapy -> Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|
| OG001 | Chemotherapy -> Talazoparib | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Days 1 of each 3-week cycle for 6 cycles. In maintenance period, participants received talazoparib 0.75 mg self-administered orally once a day, every day of each 6-week cycle. |
| OG002 | Chemotherapy + Bevacizumab -> Bevacizumab | In chemotherapy period, participants received paclitaxel 175 mg/m^2 IV over 3 hours followed by carboplatin AUC 5 or 6 IV over 15-60 minutes on Day 1 of each 3-week cycle for 6 cycles along with bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle beginning with Cycle 2 for adjuvant participants, and for neoadjuvant participants, bevacizumab was given on Day 1 of each 3-week cycle for Cycles 1, 2, 5, and 6. In maintenance period, participants received bevacizumab 15 mg/kg administered IV on Days 1 and 22 of each 6-week cycle. |
|