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Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

Primary Purpose

Urothelial Carcinoma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Niraparib
Best supportive care
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participant must have histologically/cytologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium (transitional cell carcinoma either pure or mixed histology)
  2. Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
  3. Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of platinum containing regimen (cisplatin or carboplatin)
  4. No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 guidelines )
  5. Patients must be enrolled within 4 weeks of scans demonstrating stable disease/partial-complete response and no more than 6 weeks after receiving the last standard chemotherapy dose
  6. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Participant must be ≥ 18 years of age
  8. Participant must have adequate bone marrow and organ function, defined as follows:

    • Absolute neutrophil count ≥ 1,500/µL
    • Platelets ≥ 100,000/µL
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
    • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
    • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  9. Participant receiving corticosteroids is eligible if their dose is stable for least 4 weeks prior to initiating protocol therapy.
  10. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  11. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):

    • ≥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 an ultrasound. 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.

    Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

  12. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
  13. Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
  14. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
  15. Blood sample availability, to determine germline BRCA mutation status
  16. Archived tumor tissue sample availability to determine homologous recombination deficiency (HRD) status

Exclusion Criteria:

  1. Participant must not be simultaneously enrolled in any interventional clinical trial
  2. Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  3. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
  4. Participant must not have received radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  5. Participant must not have a known hypersensitivity to niraparib components or excipients.
  6. Participant must not have been treated previously with a known PARP inhibitor agent
  7. Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
  8. Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  9. Participant must not have experienced any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks.
  10. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  11. Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
  12. Participant must not have a diagnosis of any other malignancy within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.
  13. Participant must not have history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.

Sites / Locations

  • Azienda Sanitaria Locale CN2 - Alba e Bra
  • Azienda USL Toscana Sud Est, Ospedale San Donato
  • Istituto Tumori Giovanni Paolo II - IRCCS
  • Presidio Ospedaliero Senatore A.Perrino
  • Azienda Ospedaliero-Universitaria
  • Azienda Ospedaliera Cannizzaro
  • Azienda Ospedaliero-Universitaria Careggi
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS
  • Istituto Nazionale Tumori IRCCS
  • Istituto Nazionale Tumori - Fondazione G.Pascale IRCCS
  • Istituto Oncologico Veneto IRCCS
  • ASL Piacenza, Dipartimento Oncologico
  • Azienda Ospedaliero-Universitaria Pisana, Ospedale Santa Chiara
  • Ausl - Irccs
  • Irccs Crob
  • Azienda Ospedaliera San Camillo Forlanini
  • Campus Biomedico
  • SCDU Oncologia Medica, AO Ordine Mauriziano
  • Presidio Ospedaliero Santa Chiara - APSS
  • AOU Santa Maria della Misericordia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Arm

Control Arm

Arm Description

Patients assigned to experimental arm will receive Niraparib 300 mg or 200 mg daily (based on weight and platelet count) plus best supportive care (BSC), in 28-day cycles, until disease progression or unacceptable toxicity or death.

Patients assigned to control arm will receive best supportive care alone, until disease progression or death.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
PFS is defined as the time from the date of randomization to the earlier date of assessment of progression, or death by any cause in the absence of progression. Progression will be assessed following Response Evaluation Criteria In Solid Tumors (RECIST) criteria ( v.1.1 ), using investigator's review.

Secondary Outcome Measures

Objective response rate (ORR)
ORR is defined as the percentage of patients with complete response (CR) or partial response (PR), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v.1.1)
Duration of response (DoR)
DoR is defined as the time between the date of documented response and the date of first documented sign of clinical or radiological progression
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death by any cause
Progression-free survival at 6 months
Progression-free survival at 6 month is defined as the rate of patients who are progression-free 6 months after randomization
Treatment-emergent adverse events (TEAEs)
The study will collect information about the incidence of treatment-emergent AEs (TEAEs), coded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Health-related quality of life
The study will collect information about patient health-related quality of life using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. Multi-item scales are computed by calculating the mean raw scores of single items and transforming them linearly so that all scales range from 0 to 100. For single items, only linear transformation is performed. For functioning scales (i.e. those exploring physical, role, emotional, cognitive and social functioning and global health status), the higher the value the better the level of function; for symptoms scales and items, the higher the value the worse the severity of symptoms.

Full Information

First Posted
May 6, 2019
Last Updated
May 16, 2022
Sponsor
University of Turin, Italy
Collaborators
Tesaro, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03945084
Brief Title
Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy
Official Title
A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Care as Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After First-line Platinum-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
Collaborators
Tesaro, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study conducted in patients affected by unresectable, locally advanced or metastatic urothelial cancer receiving niraparib plus best supportive care versus best supportive care as maintenance therapy after a first-line platinum-based chemotherapy. The primary objective of the trial is to evaluate the efficacy of niraparib plus Best Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of progression-free survival (PFS), in patients with locally advanced or metastatic urothelial cancer that obtained disease control (objective response or stable disease) with first-line platinum-based chemotherapy.
Detailed Description
This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study conducted in patients affected by unresectable, locally advanced or metastatic urothelial cancer receiving niraparib plus best supportive care versus best supportive care as maintenance therapy after a first-line platinum-based chemotherapy. The primary objective of the trial is to evaluate the efficacy of niraparib plus Best Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of progression-free survival (PFS), in patients with locally advanced or metastatic urothelial cancer that obtained disease control (objective response or stable disease) with first-line platinum-based chemotherapy. Poly-adenosine diphosphate ribose polymerase (PARP) inhibitors sensitivity is based on the presence of truncating and missense mutations in genes associated with the homologous recombination pathways. In The Cancer Genome Atlas dataset approximately 34% of bladder urothelial carcinoma harbored these mutations. Furthermore, in this study we plan to select a population potentially sensible to niraparib, by enrolling patients responding to platinum, indeed we know that there is a cross-sensitivity and a cross-resistance between platinum drugs and PARP inhibitors in urothelial carcinoma. PFS is commonly adopted as primary endpoint in randomized phase II trials. Randomized design for phase II trials has been increasingly adopted in recent years, to allow a formal comparison between experimental and standard treatment. This should lead to a better interpretation of the results obtained with the experimental treatment, that are in most cases difficult to interpret in the absence of controls. The sample size of the study is calculated with "relaxed" statistical criteria. The study design will verify if the experimental treatment (Niraparib) is promising enough to warrant a phase 3 trial for efficacy compared to observation. A total of 65 PFS events are needed to provide 80% power to detect an hazard ratio (HR) of 0.57 (1.75), corresponding to a median increase in progression-free survival from 4 to 7 months, with one-tailed alpha 0.1. With an accrual duration of 24 months, and additional 6 months of follow up after the completion of recruitment, 77 patient need to be randomized (26 assigned to control arm and 51 assigned to experimental arm) to obtain the 65 events needed. Sample size of the phase II trial is too small to plan a formal analysis of interaction of treatment efficacy with type of response at first line treatment (i.e. objective response vs. stable disease). However, type of response to first line treatment will be among stratification factor for randomization, so the 2 treatment groups will be balanced. Exploratory subgroup analysis of treatment efficacy in patient who have obtained objective response with first line and in patients who have obtained stable disease with first line will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Patients assigned to experimental arm will receive Niraparib 300 mg or 200 mg daily (based on weight and platelet count) plus best supportive care (BSC), in 28-day cycles, until disease progression or unacceptable toxicity or death.
Arm Title
Control Arm
Arm Type
Other
Arm Description
Patients assigned to control arm will receive best supportive care alone, until disease progression or death.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Other Intervention Name(s)
Zejula
Intervention Description
Niraparib will be administered as a flat-fixed, continuous daily dose: ≥77 kg and ≥150,000 µL: 300 mg (3 X 100 mg capsules) daily <77 kg or <150,000 µL: 200 mg (2 X 100 mg capsules) daily* * For patients whose starting dose is 2 capsules once daily, escalation to 3 capsules once daily will be permitted if no treatment interruption or discontinuation will be required during the first 2 cycles of therapy
Intervention Type
Other
Intervention Name(s)
Best supportive care
Intervention Description
In both treatment arms, Best Supportive Care (BSC) is defined as a comprehensive assessment of symptoms, with timely application of symptom control measures, in order to maximize patient's quality of life. BSC does not include any active antitumoral treatment, and will be given according to local guidelines and the normal practice of each participating institution. BSC will include use of opioid analgesics, other supportive drugs, radiotherapy, administered with the exclusive aim of improving tumor symptoms (e.g. pain, haematuria, etc.), according to Investigator's judgment.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from the date of randomization to the earlier date of assessment of progression, or death by any cause in the absence of progression. Progression will be assessed following Response Evaluation Criteria In Solid Tumors (RECIST) criteria ( v.1.1 ), using investigator's review.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as the percentage of patients with complete response (CR) or partial response (PR), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v.1.1)
Time Frame
Up to 3 years
Title
Duration of response (DoR)
Description
DoR is defined as the time between the date of documented response and the date of first documented sign of clinical or radiological progression
Time Frame
Up to 3 years
Title
Overall survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death by any cause
Time Frame
Up to 3 years
Title
Progression-free survival at 6 months
Description
Progression-free survival at 6 month is defined as the rate of patients who are progression-free 6 months after randomization
Time Frame
6 months
Title
Treatment-emergent adverse events (TEAEs)
Description
The study will collect information about the incidence of treatment-emergent AEs (TEAEs), coded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame
Up to 3 years
Title
Health-related quality of life
Description
The study will collect information about patient health-related quality of life using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. Multi-item scales are computed by calculating the mean raw scores of single items and transforming them linearly so that all scales range from 0 to 100. For single items, only linear transformation is performed. For functioning scales (i.e. those exploring physical, role, emotional, cognitive and social functioning and global health status), the higher the value the better the level of function; for symptoms scales and items, the higher the value the worse the severity of symptoms.
Time Frame
Up to 3 years
Other Pre-specified Outcome Measures:
Title
BReast CAncer gene (BRCA) mutation status (exploratory)
Description
The study will collect blood sample from archival material of each patient at screening to assess BRCA mutation status.
Time Frame
Assessed on blood sample collected at baseline
Title
Homologous Recombination Deficiency (HRD) status (exploratory)
Description
The study will collect tumor tissue from archival material of each patient at screening to assess HRD status
Time Frame
Assessed on tumor tissue collected at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must have histologically/cytologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium (transitional cell carcinoma either pure or mixed histology) Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of platinum containing regimen (cisplatin or carboplatin) No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 guidelines ) Patients must be enrolled within 4 weeks of scans demonstrating stable disease/partial-complete response and no more than 6 weeks after receiving the last standard chemotherapy dose Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Participant must be ≥ 18 years of age Participant must have adequate bone marrow and organ function, defined as follows: Absolute neutrophil count ≥ 1,500/µL Platelets ≥ 100,000/µL Hemoglobin ≥ 9 g/dL Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN Participant receiving corticosteroids is eligible if their dose is stable for least 4 weeks prior to initiating protocol therapy. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons): ≥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 an ultrasound. 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. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment. Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent Blood sample availability, to determine germline BRCA mutation status Archived tumor tissue sample availability to determine homologous recombination deficiency (HRD) status Exclusion Criteria: Participant must not be simultaneously enrolled in any interventional clinical trial Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy. Participant must not have received radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy. Participant must not have a known hypersensitivity to niraparib components or excipients. Participant must not have been treated previously with a known PARP inhibitor agent Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy. Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. Participant must not have experienced any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent Participant must not have a diagnosis of any other malignancy within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms. Participant must not have history of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Di Maio, MD
Organizational Affiliation
Department of Oncology, University of Turin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Sanitaria Locale CN2 - Alba e Bra
City
Alba
Country
Italy
Facility Name
Azienda USL Toscana Sud Est, Ospedale San Donato
City
Arezzo
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II - IRCCS
City
Bari
Country
Italy
Facility Name
Presidio Ospedaliero Senatore A.Perrino
City
Brindisi
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria
City
Cagliari
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS
City
Meldola
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS
City
Milano
Country
Italy
Facility Name
Istituto Nazionale Tumori - Fondazione G.Pascale IRCCS
City
Napoli
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
Country
Italy
Facility Name
ASL Piacenza, Dipartimento Oncologico
City
Piacenza
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana, Ospedale Santa Chiara
City
Pisa
Country
Italy
Facility Name
Ausl - Irccs
City
Reggio Emilia
Country
Italy
Facility Name
Irccs Crob
City
Rionero In Vulture
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
Country
Italy
Facility Name
Campus Biomedico
City
Roma
Country
Italy
Facility Name
SCDU Oncologia Medica, AO Ordine Mauriziano
City
Torino
Country
Italy
Facility Name
Presidio Ospedaliero Santa Chiara - APSS
City
Trento
Country
Italy
Facility Name
AOU Santa Maria della Misericordia
City
Udine
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.urotoday.com/conference-highlights/asco-gu-2022/asco-gu-2022-bladder-cancer/135451-asco-gu-2022-meet-uro12-phase-ii-study-of-niraparib-plus-best-supportive-care-vs-bsc-alone-as-maintenance-treatment-in-advanced-urothelial-carcinoma-patients-whose-disease-did-not-progress-after-first-line-platinum-based-chemotherapy.html
Description
Description of the results presented at ASCO GU 2022

Learn more about this trial

Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

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