NL-OMON55032
Completed
Phase 3
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302) - QED_PROOF 302
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations
- Sponsor
- QED Therapeutics, Inc.
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Are \>\=18 years of age (\>\=20 years of age in Taiwan) of either sex.
- •2\. Have signed informed consent.
- •3\. Are randomized within 120 days following nephroureterectomy, distal
- •ureterectomy, or cystectomy. Note: at the time of definitive surgery,
- •lymph node dissection (LND) should be performed in cases of suspected
- •lymph node invasion based on preoperative imaging or intraoperative
- •findings. In other cases, LND is to be performed in accordance with
- •surgeon preferences/local standard practices. Additional details on
- •recommended standards for LND are provided in the protocol.
- •4\. Have histologically or cytologically confirmed, invasive urothelial
Exclusion Criteria
- •1\. Presence of positive invasive surgical margins following
- •nephroureterectomy, distal ureterectomy, or cystectomy. In subjects not
- •eligible for further surgery, radiotherapy, or other efficacious treatment,
- •microscopic positive noninvasive margins (eg, carcinoma in situ) without
- •gross residual disease are allowed.
- •2\. Have received Bacillus Calmette\-Guerin (BCG) or other intravesical
- •therapy for nonmuscle invasive bladder cancer (NMIBC) within the
- •previous 30 days.
- •3\. Are currently receiving or are planning to receive during participation
- •in this study, treatment with agents that are known moderate or strong
Outcomes
Primary Outcomes
Not specified
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