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BRIEF TITLE: Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

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)


  • Org Study ID: QBGJ398-302
  • Secondary ID: 2019-003248-63
  • NCT ID: NCT04197986
  • NCT Alias:
  • Sponsor: QED Therapeutics, Inc. - Industry
  • Source: QED Therapeutics, Inc.

Brief Summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, infigratinib, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or translocations [ie, rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence.

Overal Status Start Date Phase Study Type
Recruiting March 11, 2020 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Centrally determine disease-free survival (DFS)

Primary Outcome 1 - Time Frame: Randomization through 1 year after end of treatment

Condition:

  • Upper Tract Urothelial Carcinomas
  • Urothelial Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria

1. Have histologically or cytologically confirmed, invasive urothelial carcinoma with
susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal
ureterectomy, or cystectomy

2. If the patient received neoadjuvant chemotherapy, pathologic stage at surgical
resection must be AJCC Stage ≥ ypT2 and/or yN+.

3. If the patient did not receive neoadjuvant chemotherapy:

1. Must be ineligible to receive cisplatin-based adjuvant chemotherapy per the
Galsky criteria:

- creatinine clearance < 60cc/min or

- ≥ Grade 2 hearing loss or

- ≥ Grade 2 neuropathy)

2. Pathologic stage must be AJCC Stage ≥pT2 pN0-2 M0 (post-lymphadenectomy or no
lymphadenectomy [pNx]) for upper tract disease.

3. Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer).

4. Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

5. Patients must have no evidence of metastatic disease based on screening CT or MRI.

Exclusion Criteria:

1. Presence of positive surgical margins following nephroureterectomy, distal
ureterectomy, or cystectomy.

2. Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for
Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.

3. Have previously or currently is receiving treatment with a mitogen-activated protein
kinase (MEK) or selective FGFR inhibitor.

4. Have impaired gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral infigratinib (eg, active ulcerative diseases,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel
resection)

5. Have current evidence of corneal or retinal disorder/keratopathy.

6. Have a history and/or current evidence of extensive tissue calcification.

7. Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg,
parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis),
unless well controlled.

8. Are currently receiving or are planning to receive during participation in this study,
treatment with agents that are known strong inducers or inhibitors of CYP3A4 and
medications which increase serum phosphorus and/or calcium concentration.

9. Clinically significant cardiac disease.

10. Recent (< 3 months prior to first dose of study drug) transient ischemic attack or
stroke.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Corina Andresen, MD

Role: Study Director

Affiliation: QED Therapeutics

Overall Contact

Name: QED Therapeutics

Phone: 1-877-280-5655

Email: Proof302.ct@qedtx.com

Locations

Facility Status Contact
Arizona Oncology Associates
Tucson, Arizona 85711
United States
Recruiting Stacey Kimbell
520-668-5678
stacey.kimbell@usoncology.com
City of Hope
Duarte, California 91010
United States
Recruiting Sumanta Pal, M.D.
626-256-4673
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Cheryl Kefauver
323-865-3000
daneshma@usc.edu
Urological Research Network CORP
Hialeah, Florida 33016
United States
Recruiting Isabel H Lopez
786-431-2014
isabel@besturology.net
Woodlands Medical Specialist
Pensacola, Florida 32503
United States
Recruiting Leslie Bellamy
850-696-4423
lbellamy@woodlandsmed.com
Oncology Hematology Care
Cincinnati, Ohio 45242
United States
Recruiting Doug Hart
513-751-2273
douglas.hart@usoncology.com
Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Recruiting Roxie Felton
615-250-9240
rcfelton@ua-pc.com
Houston Methodist Hospital- Department of Urology
Houston, Texas 77030
United States
Recruiting Cinthya Yesenia Obando Perez Obando Perez, MD
346-238-6123
cobandoperez@houstonmethodist.com
Texas Oncology
Longview, Texas 75601
United States
Recruiting Shelly Maxfield
903-757-2122
shelly.maxfield@usoncology.com