Breast Cancer Clinical Trial
Official title:
A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB047986 in Subjects With Advanced Malignancies
This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1
and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety,
tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose
of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of
patients with solid tumors. Each patient group will participate in a phase of the study which
is divided into two parts. The patient groups will be enrolled in a sequential manner
starting with Patient Group 1.
Patient Group 1
Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986
as monotherapy.
Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and
pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced
malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of
INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial
pharmacologic effect. These doses will be used in Part 2 of the study.
Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and
preliminary clinical activity of INCB047986 using the doses identified in Part 1.
Group 2
Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or
urothelial cancer.
Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in
combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid
tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second
line), triple-negative breast cancer (second line) or urothelial cancer (second line).
Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers,
and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients
enrolled in this phase will be limited to those with advanced or metastatic pancreatic
cancer.
n/a
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