Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
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ClinicalTrials.gov Identifier: NCT04197986 |
Recruitment Status :
Recruiting
First Posted : December 13, 2019
Last Update Posted : December 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Upper Tract Urothelial Carcinomas Urothelial Bladder Cancer | Drug: Infigratinib Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 218 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants will be randomly assigned (1:1) to receive oral infigratinib phosphate or placebo |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | As a double-blind study, participants, investigators, study monitor(s) and the clinical study team will be blinded to the treatment administered. |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | March 11, 2020 |
Estimated Primary Completion Date : | January 31, 2024 |
Estimated Study Completion Date : | January 31, 2025 |

Arm | Intervention/treatment |
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Experimental: Infigratinib 125 mg
Participants will be randomly assigned (1:1) to receive oral infigratinib administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks
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Drug: Infigratinib
Participants randomly assigned to infigratinib will receive hard gelatin capsules for oral administration of infigratinib 125 mg once a day (administered as one 100-mg capsule and one 25-mg capsule) using a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
Other Names:
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Placebo Comparator: Placebo
Participants will be randomly assigned (1:1) to receive oral placebo administered once daily for the first 3 weeks (21 days) of each 28-day cycle for a maximum of 52 weeks
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Drug: Placebo
Participants randomly assigned to placebo will receive placebo matching in appearance the investigational product (infigratinib), which will be provided as hard gelatin capsules for oral use and will be administered once daily on a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule. |
- Centrally determine disease-free survival (DFS) [ Time Frame: Randomization through 1 year after end of treatment ]
- Compare DFS including intraluminal low-risk recurrence [ Time Frame: Randomization through up to an approximated 5 years (60 months) after end of treatment ]
- Compare metastasis-free survival (MFS) [ Time Frame: Randomization through 1 year after end of treatment ]
- Compare overall survival (OS) [ Time Frame: Randomization through 1 year after end of treatment ]
- Compare investigator-reviewed DFS [ Time Frame: Randomization through 1 year after end of treatment ]
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability [ Time Frame: 30-Day Post-Treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy
- If the patient received neoadjuvant chemotherapy, pathologic stage at surgical resection must be AJCC Stage ≥ ypT2 and/or yN+.
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If the patient did not receive neoadjuvant chemotherapy:
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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)
- Pathologic stage must be AJCC Stage ≥pT2 pN0-2 M0 (post-lymphadenectomy or no lymphadenectomy [pNx]) for upper tract disease.
- Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer).
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- Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Patients must have no evidence of metastatic disease based on screening CT or MRI.
Exclusion Criteria:
- Presence of positive surgical margins following nephroureterectomy, distal ureterectomy, or cystectomy.
- Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.
- Have previously or currently is receiving treatment with a mitogen-activated protein kinase (MEK) or selective FGFR inhibitor.
- 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)
- Have current evidence of corneal or retinal disorder/keratopathy.
- Have a history and/or current evidence of extensive tissue calcification.
- Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis), unless well controlled.
- 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.
- Clinically significant cardiac disease.
- Recent (< 3 months prior to first dose of study drug) transient ischemic attack or stroke.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197986
Contact: QED Therapeutics | 1-877-280-5655 | Proof302.ct@qedtx.com |

Study Director: | Corina Andresen, MD | QED Therapeutics |
Responsible Party: | QED Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT04197986 |
Other Study ID Numbers: |
QBGJ398-302 2019-003248-63 ( EudraCT Number ) |
First Posted: | December 13, 2019 Key Record Dates |
Last Update Posted: | December 24, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
FGFR3 Genetic Alterations upper tract urothelial carcinomas UTUC Invasive Urothelial Carcinoma Fibroblast growth factor receptor inhibitor BGJ398 |
FGFR3 urothelial bladder cancer UBC Infigratinib phosphate Infigratinib Adjuvant |
Carcinoma Urinary Bladder Neoplasms Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |