An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies

Summary

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.

Conditions

• Solid Tumor
• Hodgkin's Lymphoma
• NHL (Non-Hodgkin Lymphoma)
• Pancreatic Cancer
• Breast Cancer
• UC (Ureter and Urethera)
• Advanced Cancer
• Metastatic Cancer

Interventions

DRUG

INCB047986

Initial cohort dose of INCB047986 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria

DRUG

INCB047986

INCB047986 tablets administered orally at the protocol specified dose and frequency

DRUG

Gemcitabine

Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency

DRUG

nab-paclitaxel

nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency

Sponsors & Collaborators

• Incyte Corporation

  lead INDUSTRY

Principal Investigators

• William Williams, M.D. · Incyte Corporation

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• United States

Study Locations