Brief Title: Cisplatin and Gemcitabine Hydrochloride With or Without ATR Kinase Inhibitor M6620 in Treating Patients With Metastatic Urothelial Cancer

INTRODUCTION

• Org Study ID: NCI-2015-01642
• Secondary ID: NCI-2015-01642, PHII-135, 9947, 9947, N01CM00038, UM1CA186690, UM1CA186717
• NTC ID: NCT02567409
• Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with
or without ATR kinase inhibitor M6620 works in treating patients with urothelial cancer that
has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as
cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine
hydrochloride work better alone or with ATR kinase inhibitor M6620 in treating patients with
urothelial cancer.

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DETAILED DESCRIPTION

PRIMARY OBJECTIVES:

I. To determine if the addition of ATR kinase inhibitor M6620 (M6620 [VX-970]) to
cisplatin/gemcitabine hydrochloride (gemcitabine) improves progression-free survival (PFS)
relative to cisplatin/gemcitabine alone.

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) with the addition of M6620 (VX-970) to
cisplatin/gemcitabine relative to cisplatin/gemcitabine alone.

II. To compare tumor response rate with the addition of M6620 (VX-970) to
cisplatin/gemcitabine relative to cisplatin/gemcitabine alone.

III. To compare safety with the addition of M6620 (VX-970) to cisplatin/gemcitabine relative
to cisplatin/gemcitabine alone.

IV. To assess the role of p53 status in predicting response to M6620 (VX-970)-based therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days
1 and 8, and cisplatin IV over 60 minutes on day 1. Patients also receive ATR kinase
inhibitor M6620 IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for 6
cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive gemcitabine hydrochloride and cisplatin as in Arm A.

After completion of study treatment, patients are followed up to 36 months.

• Overall Status
  Recruiting
• Start Date
  August 19, 2016
• Phase
  Phase 2
• Study Type
  Interventional