A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Careas Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy (MEET URO 12)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita' Degli Studi Di Torino

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519519-32-00

EudraCT number

2018-004147-24

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Compare maintenance treatment with Niraparib associated with the best supportive
therapy the best supportive therapy alone in patients with locally advanced or
metastatic urothelial tumor who have achieved disease control (objective response or
disease stability) with a first chemotherapy line containing platinum, in order to
determine whether maintenance treatment with Niraparib is effective in terms of
prolonging disease progression-free survival.

Conditions and MedDRA coding

urothelial cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Established histological or cytological diagnosis of non-resectable or metastatic locally advanced non-resectable urothelial transitional tumor (transitional cell carcinoma both with pure and mixed histology)
2. Measurable disease according to RECIST (v1.1) before starting the first chemotherapy line
3. The first chemotherapy line must have been performed with at least 4 cycles and no more than 6 cycles of a regimen containing platinum (cisplatin or carboplatin)
4. Absence of disease progression after completion of the first chemotherapy line (complete response, partial response or disease stability according to RECIST criteria v1.1)
5. Patients should be enrolled within 28 days of a radiological survey demonstrating disease stability or partial / complete disease response and no more than 42 days after receiving the last dose of chemotherapy
6. Availability of a blood sample to determine the state of germline mutations of BRCA genes
7. Availability of a sample of tumor tissue in the archive to determine the status of the genes involved in the mechanism of homologous recombination (HRD)
8. ECOG performance status 0-1

Exclusion criteria 6

1. Known hypersensitivity to the components of Niraparib
2. Note active liver disease
3. Previous treatment with a PARP inhibitor agent
4. Pre-existing toxicity due to previous therapies of degree> 1 according to NCI CTCAE v4.0; however, alopecia, sensory neuropathy (grade 2 or lower), or other grade 2 or lower toxicities that do not pose a risk to the patient at the trial according PI is accepted
5. Known history of bone marrow compression or meningeal carcinosis or evidence of symptomatic brain disease or leptomeningi at screening CT or RMN images. Encephalic metastases treated, stable and asymptomatic are permitted
6. The diagnosis of other cancers in the last 2 years prior to randomization; are admitted and therefore exceptions are cutaneous squamous tumor or cutaneously treated skin basaloma, in situ carcinoma of the breast or of the cervix, the low-grade prostatic tumor in active surveillance or the prostate tumor already subjected to prostatectomy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free survival (PFS)

Secondary endpoints 6

1. Proportion of objective answers
2. Duration of the answer
3. Global survival
4. Proportion of progression-free patients at 6 months from randomization.
5. Safety and tolerability
6. Quality of life (patient-reported outcomes)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita' Degli Studi Di Torino

Sponsor organisation

Universita' Degli Studi Di Torino

Address

Via Giuseppe Verdi 8

City

Turin

Postcode

10124

Country

Italy

Scientific contact point

Organisation

Universita' Degli Studi Di Torino

Contact name

Massimo Di Maio

Public contact point

Organisation

Universita' Degli Studi Di Torino

Contact name

Massimo Di Maio

Third parties 1

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications