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

  • STATUS
    Recruiting
  • End date
    May 26, 2023
  • participants needed
    43
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 26 January 2021
cancer
calcium
white blood cell count
carcinoma
growth factor
neutrophil count
bladder cancer
invasive bladder cancer
transurethral resection
cystoscopy
bladder tumor
bladder carcinoma
transurethral bladder excision

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).

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.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Non Muscle Invasive Bladder Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, NMIBC, Urothelial Carcinoma Recurrent, carcinoma of the bladder, recurrent urothelial carcinoma, bladder tumor
Treatment pemigatinib
Clinical Study IdentifierNCT03914794
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or Bladder Disorders or NMIBC or Non Muscle Invasive Bladder Cancer or bladder disorder or urinary tract neoplasm or bladder cancer ...?
Do you have any of these conditions: urinary tract neoplasm or NMIBC or bladder tumor or bladder cancer or recurrent urothelial carcinoma or carcinoma of the bladder or Bladder Disorders ...?
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
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