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Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer

2020-01-19 11:04:54 | BioPortfolio

Summary

This phase I/II trial studies the side effects of infigratinib before surgery in treating patients with upper tract urothelial cancer. Infigratinib may stop the growth of tumor cells by blocking the activities of a gene called FGFR needed for cell growth. Giving infigratinib before surgery may cause the tumor to shrink, which may make the surgical procedure easier and/or reduce the need for more extensive surgery.

Description

PRIMARY OBJECTIVE:

I. Evaluate the tolerability of infigratinib in patients with low-grade and high-grade platinum ineligible upper tract urothelial carcinoma (UTUC).

SECONDARY OBJECTIVES:

I. Assess tolerability in those with GFR 30-49. II. Evaluate the objective response rate (complete response [CR] + partial response [PR]) of infigratinib after 2 cycles in UTUC with and without FGFR3 alterations.

III. Correlate tumor tissue FGFR3 alteration (presence/absence, alteration type, and clonal status) with response and occurrence/severity of adverse events (AEs) such as hyperphosphatemia.

IV. Evaluate upper tract, bladder and local/distant recurrence within 12 months.

V. Evaluate renal function pre-treatment and after two treatments.

EXPLORATORY OBJECTIVES:

I. Explore intra-tumor heterogeneity, gene expression profiles, and changes in tumor microenvironment using single cell ribonucleic acid (RNA) sequencing (scRNA-seq) and CyTOF pre and post treatment to identify potential mechanisms of response and/or resistance, and correlation with the occurrence/severity of AEs.

II. Explore urinary/upper tract washing FGFR3 alterations as potential biomarker for detection and response.

III. Explore cell free deoxyribonucleic acid (cfDNA) for detection of FGFR3 alterations and as a predictor of response.

OUTLINE:

Patients receive infigratinib orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. During weeks 8-9 (at least 48 hours after last dose of infigratinib), patients undergo surgery.

After completion of study treatment, patients are followed up at 30 days, then every 3 months for up to 1 year after surgery.

Study Design

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Intervention

Infigratinib, Surgical Procedure

Location

M D Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-19T11:04:54-0500

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Medical and Biotech [MESH] Definitions

Recesses of the kidney pelvis which divides into two wide, cup-shaped major renal calices, with each major calix subdivided into 7 to 14 minor calices. Urine empties into a minor calix from collecting tubules, then passes through the major calix, renal pelvis, and ureter to enter the urinary bladder. (From Moore, Clinically Oriented Anatomy, 3d ed, p211)

The insertion of a catheter through the skin and body wall into the kidney pelvis, mainly to provide urine drainage where the ureter is not functional. It is used also to remove or dissolve renal calculi and to diagnose ureteral obstruction.

Surgical procedure to widen a woman's pelvis during childbirth.

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

Long convoluted tubules in the nephrons. They collect filtrate from blood passing through the KIDNEY GLOMERULUS and process this filtrate into URINE. Each renal tubule consists of a BOWMAN CAPSULE; PROXIMAL KIDNEY TUBULE; LOOP OF HENLE; DISTAL KIDNEY TUBULE; and KIDNEY COLLECTING DUCT leading to the central cavity of the kidney (KIDNEY PELVIS) that connects to the URETER.

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