A phase 2 trial of GN (gemcitabine + nedaplatin) therapy for advanced urothelial cancer patients with pre-treatment of cisplatin or carboplatin.

A phase 2 trial of GN (gemcitabine + nedaplatin) therapy for advanced urothelial cancer patients with pre-treatment of cisplatin or carboplatin. - GN for UC with pre-platinum-based-drug-treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021298

Enrollment

Registered

2016-03-04

Start date

2016-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urothelial cancer

Interventions

intravenous drip of gemcitabine and nedaplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients histologically confirmed urothelial cancer 2)Patinets with prior treatment of cisplatin or carboplatin 3)Patients with informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with sever bone marrow suppression 2) Patinets with interstitial pneumonitis or lung fibrosis 3) Patients with prior radiotherapy for chest 4) Patients with hypersensitivity reaction for the protocol drugs 5) Patients without histological diagnosis 6) Patients with prior therapy used nedaplatin 7) Patients without lesions assessed by RECISTv1.1

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
adverse event, disease control rate, progression free survival, overall survival, quality of life	—

Countries

Japan

Contacts

Public ContactSei Naito

Yamagata University Department of Urology

seinaitoh@yahoo.co.jp023-628-5368

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026