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A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

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ClinicalTrials.gov Identifier: NCT03914794
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
Complete response rate of pemigatinib therapy [ Time Frame: 6 weeks ]
The number of participants with a complete response to pemigatinib therapy. Tumor complete response is defined as the complete absence of any stage bladder tumor on post-treatment Transurethral Resection of a Bladder Tumor (TURBT) and no evidence of recurrent urothelial carcinoma on post-treatment urine cytology.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Characterize the safety profile of pemigatinib therapy [ Time Frame: 4 years ]
    Number of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 toxicities
  • Number of Participants with Complete Response and FGFR3 Mutational Status [ Time Frame: Up to 4 weeks ]
  • Number of Participants with Non-Muscle Invasive Bladder Cancer (NMIBC) and Complete Response [ Time Frame: Up to 4 years ]
    Number of participants with complete response rate and baseline NMIBC risk group (low- vs. intermediate-risk)
  • Maximal concentration (Cmax, nmol/L) of pemigatinib in urothelial tissue at post-treatment TURBT [ Time Frame: Up to 4 weeks ]
  • Relapse Free Survival (RFS) at 6 months [ Time Frame: 6 months ]
    Number of months from achieving a complete response at initial post-treatment TURBT until relapse.
  • Relapse Free Survival (RFS) at 12 months [ Time Frame: 12 months ]
    Number of months from achieving a complete response at initial post-treatment TURBT until relapse.
  • Relapse Free Survival (RFS) at 24 months [ Time Frame: 24 months ]
    Number of months from achieving a complete response at initial post-treatment TURBT until relapse.
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 A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
Official Title  ICMJE Phase 2 Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
Brief Summary This phase II trial studies how well Pemigatinib (an orally administered inhibitor of fibroblast growth factor receptors 1, 2, and 3) works in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior history of low- or intermediate-risk NMIBC tumors. Participants will receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).
Detailed Description It is a single-arm phase 2 window of opportunity study to assess the antineoplastic activity of pemigatinib in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior history of low- or intermediate-risk NMIBC tumors. Enrolled patients will receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT). The primary endpoint will be complete response rate as determined at TURBT. Secondary endpoints will include safety profile, associations between complete response rate and tumor mutation/fusion status (e.g. FGFR3 specifically, others will also be examined) and NMIBC risk group (low- vs. intermediate-risk), and assessment of pemigatinib post-treatment urothelial tissue concentrations. The study will be conducted at 4-5 high volume bladder cancer institutions within the US and managed through the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center clinical research office.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • NMIBC
  • Non-Muscle Invasive Bladder Cancer
  • Urothelial Carcinoma Recurrent
Intervention  ICMJE Drug: Pemigatinib
Participants will take Pemigatinib once daily on days 1 through 28 of each cycle prior to standard of care TURBT.
Other Names:
  • INCB054828
  • FGFR inhibitor INCB054828
Study Arms  ICMJE Experimental: Treatment: Pemigatinib
Patients will receive pemigatinib for 4 to 6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).
Intervention: Drug: Pemigatinib
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: April 11, 2019)
43
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC) defined according to the following characteristics:

    • Low Risk

      • Initial tumor with all of the following:
      • Solitary tumor
      • Ta tumor
      • Low-grade
      • <3 cm
      • No CIS
    • Intermediate Risk

      --- All tumors not defined in the two adjacent categories (between the category of low- and high-risk)

    • High Risk

      • T1 tumor
      • High-grade
      • CIS
      • Multiple and recurrent and large (>3 cm) Ta low-grade tumors (all conditions must be met for this point on Ta low-grade tumors)
  • Documented tumor recurrence as noted in standard of care follow up cystoscopy.
  • ECOG (WHO) performance status 0-2
  • Age ≥ 18 years old
  • Patients must have the following laboratory values:

    • White blood cell count (WBC) > 3.0 K/mm3
    • Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
    • Platelets ≥ 100 K/mm3
    • Hemoglobin (Hgb) ≥ 9 g/dL
    • Serum total bilirubin: ≤ 1.5 x ULN
    • ALT and AST ≤ 3.0 x ULN
    • Serum calcium < ULN
    • Serum phosphate < ULN
    • Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the modified Cockcroft-Gault equation
  • Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

  • Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma.
  • Patients with high grade urothelial carcinoma on their most recent urine cytology.
  • Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. (Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.)
  • Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
  • Patients who have received prior selective fibroblast growth factor receptor targeting agents (i.e. pemigatinib, dovitinib, BGJ398, AZD4547, JNJ-42756493, etc.).
  • Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities
  • Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
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: Abby Asiama 410-955-1168 aasiama1@jhmi.edu
Contact: Rana Sullivan 410-614-6337 tomalra@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914794
Other Study ID Numbers  ICMJE J18158
IRB00194271 ( Other Identifier: JHM IRB )
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: No
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE
Principal Investigator: Noah M Hahn, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date December 2019

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