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

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Apr 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Pemigatinib to see how well it works for patients with non-muscle invasive bladder cancer (NMIBC) who have had their tumors come back. The trial specifically focuses on patients who have a history of low- or intermediate-risk NMIBC tumors. If you qualify, you will take Pemigatinib for 4 to 6 weeks before having a standard procedure to remove the bladder tumors called transurethral resection of bladder tumor (TURBT).

To be eligible for this study, you need to be at least 18 years old and have had a confirmed diagnosis of low- or intermediate-risk NMIBC. You should also be able to take part in the study without any major health issues that would prevent you from receiving the medication. During the trial, participants will be monitored closely, and those who agree to join will need to provide written consent. This trial is currently recruiting participants, so if you or a loved one are interested, it might be a good opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• 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