COMPLETED

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

Conditions

Bladder Cancer NMIBC Non-Muscle Invasive Bladder Cancer Urothelial Carcinoma Recurrent Non Muscle Invasive Bladder Cancer Non-Muscle Invasive Bladder Cancer (NMIBC)Urothelial Carcinoma Urothelial Cancer Urinary Bladder Neoplasm Bladder Neoplasm Fibroblast inhibitors Pemigatinib FGFR inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-10-02

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03914794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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	* 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

Inclusion Criteria

Exclusion 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
* 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

* 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

Contacts and Locations

Principal Investigator

Noah M Hahn, MD

PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Locations (Sites)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016

United States

Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205

United States

Associated Medical Professionals Urology

Syracuse, New York, 13210

United States

Midlantic Urology

Bala-Cynwyd, Pennsylvania, 19004

United States

Keystone Urology

Lancaster, Pennsylvania, 17604

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Noah M Hahn, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-02

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-10-02

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Bladder Cancer
Non Muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC
Urothelial Carcinoma
Urothelial Cancer
Urinary Bladder Neoplasm
Bladder Neoplasm
Fibroblast inhibitors
Pemigatinib
FGFR inhibitor

Additional Relevant MeSH Terms

Bladder Cancer
NMIBC
Non-Muscle Invasive Bladder Cancer
Urothelial Carcinoma Recurrent