Phase II Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

Study Identifier:
J18158
CT.gov Identifier:
NCT03914794
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Study Complete

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Study Summary

To study 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.

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Treatment: Pemigatinib
    • Read More
  • Drug: Patients receive pemigatinib orally (PO) once daily (QD) for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo TURBT. Patients who achieve a complete response at post-treatment TURBT evaluation may receive pemigatinib PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.
  • Drug: After completion of study treatment, patients are followed up at 30 days, and then every 6 months for up to 2 years.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    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 >or= 18 years old
    • Patients must have the following laboratory values:
    • White blood cell count (WBC) > 3.0 K/mm^3
    • Absolute neutrophil count (ANC) = 1.5 K/mm^3
    • Platelets >or= 100 K/mm^3
    • Hemoglobin (Hgb) >or= 9 g/dL
    • Serum total bilirubin:
    • ALT and AST
    • Serum calcium < ULN
    • Serum phosphate < ULN
    • Serum creatinine 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is >or= 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
    • 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
    • Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Bladder
    Urinary tract