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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 : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
QED Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 2, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date February 26, 2021
Actual Study Start Date  ICMJE March 11, 2020
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
Centrally determine disease-free survival (DFS) [ Time Frame: Randomization through 1 year after end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Upper Tract Urothelial Carcinomas
  • Urothelial Bladder Cancer
Intervention  ICMJE
  • 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:
    • IP
    • Study drug
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Infigratinib
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)
218
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2025
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: QED Therapeutics 1-877-280-5655 Proof302.ct@qedtx.com
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04197986
Other Study ID Numbers  ICMJE QBGJ398-302
2019-003248-63 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party QED Therapeutics, Inc.
Study Sponsor  ICMJE QED Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Corina Andresen, MD QED Therapeutics
PRS Account QED Therapeutics, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP