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Brief Title: Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors

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

INTRODUCTION

  • Org Study ID: J18158
  • Secondary ID: IRB00194271
  • NTC ID: NCT03914794
  • Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

BRIEF 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).

DETAILED 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.

  • Overall Status
    Recruiting
  • Start Date
    October 2, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate of pemigatinib therapy

Primary Outcome 1 - Timeframe: 6 weeks

CONDITION

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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Noah M Hahn, MD

Role: Principal Investigator

Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Overall Contact

Name: Noah M Hahn, MD

Phone: 410-502-4910, 410-614-6337

Email: rzak5@jh.edu, tomalra@jhmi.edu

LOCATION

Facility Status Contact
Facility: Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21205
United States
Status: Recruiting Contact: N/A