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| Name | Class |
|---|---|
| European Commission | OTHER |
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This study will be performed in women with platinum-sensitive, high-grade serous, high-grade endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or primary peritoneal cancer (proven by central histo-pathological review).
A total of 120 subjects will be randomized (1:1:1) to three different treatment arms: (A) Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) // (B) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) // (C) Second experimental arm (arm C): Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w).
Chemotherapy treatment will be given for 6 cycles, maintenance treatment with Ganetespib will be given for a maximum of 9 months or until disease progression, maintenance treatment with Niraparib can continue until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm (arm A) | Active Comparator | Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) |
|
| First experimental arm (arm B) | Experimental | Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) |
|
| Second experimental arm (arm C) | Experimental | Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganetespib | Drug | Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 3 years 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival in BRCA Mutated Patients | Progression-free survival analysis in BRCA mutated patients | 3 years 10 months |
| Post-progression PFS (PFS2) | Post-progression PFS (PFS2) analysis |
Not provided
Inclusion Criteria:
Patients must meet the following criteria to be eligible for study entry:
Platelets ≥ 100 x 109/L
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Adequate function of the organs
Creatinine < 2 mg/dl (<177 μmol/L)
Total bilirubin ≤ 1.5 x upper limit of normal (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
SGOT/SGPT (AST/ALT) ≤ 2.5 x upper limit of normal unless liver metastases are present, in which case they must be ≤ 5 x ULN
Urinanalysis or urine dipstick for proteinuria less than 2+. Patients with ≥ 2+ on dipstick should undergo 24-hour urine collection and must demonstrate < 1 g of protein/24 hours; except the proteinuria is clearly related to a catheter in the urinary system.
≥ 45 years of age and has not had menses for >1 year
Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by imaging. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See below for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
Birth Control: Participants of childbearing potential who are sexually active and their partners must agree to the use of a highly effective form of contraception throughout their participation beginning with time of consent, during the study treatment and for 180 days after last dose of study treatment(s):
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
Progestogen-only hormonal contraception associated with inhibition of ovulation
Intrauterine device
Intrauterine hormone-releasing system
Bilateral tubal occlusion
Vasectomized partner
Sexual abstinence, if the preferred and usual lifestyle of the subject
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
Any serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | 6020 | Austria | |||
| UZLeuven |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Arm (Arm A) | Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w) Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 & d8) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2020 |
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Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) Second experimental arm (arm C): Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w)
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| Niraparib | Drug | Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) |
|
| Carboplatin | Drug | In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) |
|
| Paclitaxel | Drug | Paclitaxel dose will be 175mg/m² (q3w) |
|
| Gemcitabine | Drug | Gemcitabine dose will be 1000mg/m² (q3w, d1 & d8) |
|
| 3 years 10 months |
| Time to First Subsequent Therapy (TFST) | Time to First Subsequent Therapy (TFST) analysis | 3 years 10 months |
| Time to Second Subsequent Therapy (TSST) | Time to Second Subsequent Therapy (TSST) analysis | 3 years 10 months |
| Progression-free Survival in Patients Without BRCA Mutation or With Unknown BRCA Status | Progression-free Survival analysis in Patients without BRCA mutation or with unknown BRCA status | 3 years 10 months |
| Objective Response Rate (ORR) | Objective response rate (ORR) analysis | 3 years 10 months |
| Overall Survival (OS) | Overall survival (OS) analysis | 3 years 10 months |
| Progression-free Survival in Patients With Prior PARPi Treatment | Progression-free Survival analysis in Patients with prior PARPi treatment | 3 years 10 months |
| Progression-free Survival in Patients With One Prior Line of Therapy | Progression-free Survival analysis in Patients with one prior line of therapy | 3 years 10 months |
| Progression-free Survival in Patients With More Then One Prior Line of Therapy | Progression-free Survival analysis in Patients with more then one prior line of therapy | 3 years 10 months |
| Progression-free Survival in Patients Without Prior PARPi Treatment | Progression-free Survival analysis in Patients without prior PARPi treatment | 3 years 10 months |
| Leuven |
| Vlaams-Brabant |
| 3000 |
| Belgium |
| Centre de lutte contre le cancer Francois Baclesse | Caen | 14076 | France |
| Centre anticancereux Leon Berard | Lyon | 69008 | France |
| Assistance Publique Hôpitaux de Paris | Paris | 75004 | France |
| Universitätsmedizin Berlin Charité | Berlin | 10117 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Universitätsklinikum Dresden | Dresden | 01069 | Germany |
| Kliniken Essen Mitte, Evang. Huyssens- Stiftung/Knappschaft GmbH | Essen | 45136 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Azienda Ospedaliero Bologna | Bologna | 40138 | Italy |
| Fondazione IRCCS Istituto Nazionale dei tumori Milano | Milan | 20133 | Italy |
| Università Cattolica del Sacro Cuore | Rome | 00168 | Italy |
| FG001 | First Experimental Arm (Arm B) | Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) |
| FG002 | Second Experimental Arm (Arm C) | Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Arm (Arm A) | Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w) Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 & d8) |
| BG001 | First Experimental Arm (Arm B) | Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) |
| BG002 | Second Experimental Arm (Arm C) | Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A). | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
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| Secondary | Progression-free Survival in BRCA Mutated Patients | Progression-free survival analysis in BRCA mutated patients | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Mean | 95% Confidence Interval | months | 3 years 10 months |
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| Secondary | Post-progression PFS (PFS2) | Post-progression PFS (PFS2) analysis | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
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| Secondary | Time to First Subsequent Therapy (TFST) | Time to First Subsequent Therapy (TFST) analysis | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
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| Secondary | Time to Second Subsequent Therapy (TSST) | Time to Second Subsequent Therapy (TSST) analysis | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in Patients Without BRCA Mutation or With Unknown BRCA Status | Progression-free Survival analysis in Patients without BRCA mutation or with unknown BRCA status | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective response rate (ORR) analysis | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Count of Participants | Participants | 3 years 10 months |
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| Secondary | Overall Survival (OS) | Overall survival (OS) analysis | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in Patients With Prior PARPi Treatment | Progression-free Survival analysis in Patients with prior PARPi treatment | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in Patients With One Prior Line of Therapy | Progression-free Survival analysis in Patients with one prior line of therapy | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in Patients With More Then One Prior Line of Therapy | Progression-free Survival analysis in Patients with more then one prior line of therapy | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in Patients Without Prior PARPi Treatment | Progression-free Survival analysis in Patients without prior PARPi treatment | The primary aim of this study was to determine the efficacy of the new agent regarding progression-free survival (PFS). Therefore the main analysis, as foreseen in the protocol, combined the two study arms with Ganetespib (arms B and C) and compare it against the standard arm (arm A), both for the primary outcome as for all secondary and exploratory outcomes. | Posted | Median | 95% Confidence Interval | months | 3 years 10 months |
|
3 years 10 months
This trial consisted of a first period in which chemotherapy (CT) was administered and of a maintenance treatment (MT) period. Not all patients completed the CT or were allowed to start in the MT. Both groups were analyzed separately in order to differentiate between CT and MTevents. This result section does not accommodate for the separate reporting both groups so we reported all events in this section, differentiation can be made based on the number of patients that were at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Arm (Arm A) - Chemotherapy Phase | Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) Paclitaxel: Paclitaxel dose will be 175mg/m² (q3w) Gemcitabine: Gemcitabine dose will be 1000mg/m² (q3w, d1 & d8) | 41 | 41 | 20 | 41 | 40 | 41 |
| EG001 | First Experimental Arm (Arm B) - Chemotherapy Phase | Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) | 42 | 42 | 19 | 42 | 42 | 42 |
| EG002 | Second Experimental Arm (Arm C) - Chemotherapy Phase | Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) | 39 | 39 | 16 | 39 | 39 | 39 |
| EG003 | Standard Arm (Arm A) - Maintenance Phase | Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) | 32 | 32 | 13 | 32 | 32 | 32 |
| EG004 | First Experimental Arm (Arm B) - Maintenance Phase | Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) | 26 | 26 | 8 | 26 | 26 | 26 |
| EG005 | Second Experimental Arm (Arm C) - Maintenance Phase | Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w) | 17 | 17 | 5 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CRP increased | Infections and infestations | Non-systematic Assessment |
| ||
| Abdominal pain | General disorders | Non-systematic Assessment |
| ||
| allergic reaction NOS | Immune system disorders | Non-systematic Assessment |
| ||
| Allergic reaction to Carboplatin | Immune system disorders | Non-systematic Assessment |
| ||
| Anaphylactic shock | Infections and infestations | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Ascites | General disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dehydration | General disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Fistula | General disorders | Non-systematic Assessment |
| ||
| Gastrointestinal perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| general deterioration | General disorders | Non-systematic Assessment |
| ||
| General malaise | General disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Investigations | Non-systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal subobstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Kidney insufficiency | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Maligne pleuritis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Neutropenia | Investigations | Non-systematic Assessment |
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| pericardial effusion | Cardiac disorders | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary tuberculosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Septic shock | Infections and infestations | Non-systematic Assessment |
| ||
| Syncope | General disorders | Non-systematic Assessment |
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| Thrombocytopenia | Investigations | Non-systematic Assessment |
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| Tumor biopsy | Investigations | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| COVID-19 infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Gastro-entiritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Subileus | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Non-systematic Assessment |
| ||
| transaminases increased | Investigations | Non-systematic Assessment |
| ||
| Word finding disorders | General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| QTc prolongation | Cardiac disorders | Non-systematic Assessment |
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| abdominal cramping | General disorders | Non-systematic Assessment |
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| Abdominal pain | General disorders | Non-systematic Assessment |
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| Allergic reaction to Carboplatin | Immune system disorders | Non-systematic Assessment |
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| Alopecia | General disorders | Non-systematic Assessment |
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| Anemia | Investigations | Non-systematic Assessment |
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| Anorexia | General disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| blurry vision | Eye disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Dysgeusia | General disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Epistaxis | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| General malaise | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
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| Leucocytopenia | Investigations | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Neutropenia | Investigations | Non-systematic Assessment |
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| Peripheral neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Syncope | General disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Investigations | Non-systematic Assessment |
| ||
| Transaminases increased | Investigations | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| QTcF prolongation | Cardiac disorders | Non-systematic Assessment |
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| Abdominal bloating | General disorders | Non-systematic Assessment |
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| Alkaline phosphatase increased | General disorders | Non-systematic Assessment |
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| Creatinine increased | Investigations | Non-systematic Assessment |
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| Dysgeusia | General disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pyrosis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Weight decreased | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Reynders, SC | UZLeuven | +3216342996 | ellen.reynders@uzleuven.be |
| May 23, 2024 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| C533237 | STA 9090 |
| C545685 | niraparib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Belgium |
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| Italy |
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| France |
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| Germany |
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| OG001 | Experimental Arms (Arm B&C) | Ganetespib (150 mg/m2, d1, q3w [q3w=every three weeks]) in combination with Carboplatin (AUC5 [AUC=Area under the curve] d1, q3w i.v. [q3w=every three weeks, i.v.=intravenously]) followed by maintenance treatment: Arm B: Niraparib (200/ 300 mg oral daily, q4w [q4w=every four weeks]) Arm C: Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v. [q4w=every four weeks, i.v.=intravenously])) and Niraparib (200 mg oral daily, q4w [q4w=every four weeks]) Ganetespib: Ganetespib dose during chemotherapy will be 150mg/m² (q3w [q3w=every three weeks]) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w [q1w=every week]) Niraparib: Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD) [QD=once daily]. Carboplatin: In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) [q3w=every three weeks] In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w) [q3w=every three weeks] |
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