Urothelial CarcinomaPhase 2NCT03945084
Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy
A Phase 2 study testing Niraparib in people with Urothelial Carcinoma, run by University of Turin, Italy at 20 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Niraparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 20 sitesItaly
- Study dates
- 27 Aug 2019to 1 Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Azienda Sanitaria Locale CN2 - Alba e Bra
Alba
Azienda USL Toscana Sud Est, Ospedale San Donato
Arezzo
Istituto Tumori Giovanni Paolo II - IRCCS
Bari
Presidio Ospedaliero Senatore A.Perrino
Brindisi
Azienda Ospedaliero-Universitaria
Cagliari
Azienda Ospedaliera Cannizzaro
Catania
Azienda Ospedaliero-Universitaria Careggi
Florence
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS
Meldola
Istituto Nazionale Tumori IRCCS
Milan
Istituto Nazionale Tumori - Fondazione G.Pascale IRCCS
Naples
Istituto Oncologico Veneto IRCCS
Padova
ASL Piacenza, Dipartimento Oncologico
Piacenza
Azienda Ospedaliero-Universitaria Pisana, Ospedale Santa Chiara
Pisa
Ausl - Irccs
Reggio Emilia
Irccs Crob
Rionero in Vulture
Azienda Ospedaliera San Camillo Forlanini
Roma
Campus Biomedico
Roma
SCDU Oncologia Medica, AO Ordine Mauriziano
Torino
Presidio Ospedaliero Santa Chiara - APSS
Trento
AOU Santa Maria della Misericordia
Udine
About this study
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
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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- Niraparib, Best supportive care
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Also called Zejula
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
Best supportive careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 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. Receives: Drug: Niraparib; Other: Best supportive care |
| Control Arm | Other | Patients assigned to control arm will receive best supportive care alone, until disease progression or death. Receives: Other: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (6)
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)
Measured: Up to 3 years
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
Measured: Up to 3 years
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death by any cause
Measured: Up to 3 years
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
Measured: 6 months
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
Measured: Up to 3 years
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start27 Aug 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Principal investigator, Massimo Di Maio, University of Turin, Italy
- Investigators
- Massimo Di Maio, MD, Principal investigator, Department of Oncology, University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945084
- Sponsor's protocol ID
- Meet-URO 12
- Status last verified
- May 2022
- First submitted
- 6 May 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03945084
- Acronym / sponsor ID
- Meet-URO 12
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Niraparib, Other: Best supportive carePatients 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. |
| Control Arm | Other | Other: Best supportive carePatients assigned to control arm will receive best supportive care alone, until disease progression or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibAlso: ZejulaNiraparib 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 | Drug | Experimental Arm |
| Best supportive careIn 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. | Other | Control Arm, Experimental Arm |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 3 years
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.
6 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 3 years
Duration of response (DoR)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
Progression-free survival at 6 months
Time frame: 6 months
Treatment-emergent adverse events (TEAEs)
Time frame: Up to 3 years
Health-related quality of life
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Description of the results presented at ASCO GU 2022Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Di Maio, MD principal investigator
Department of Oncology, University of Turin
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib in people with Urothelial Carcinoma, run by University of Turin, Italy at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.