Phase 2 Window of Opportunity Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

J18158

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).

2020-10-02

2024-05-01

2025-05-01

Recruiting

Early phase I

43

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ESTIMATED'}}

2024-05-10