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INCB047986

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

Ensayo de INCYTE CORP en Solid Tumor · Hodgkin's Lymphoma · NHL (Non-Hodgkin Lymphoma) · Pancreatic Cancer · Breast Cancer · UC (Ureter and Urethera) · Advanced Cancer · Metastatic Cancer (del registro, en inglés).

Más ensayos de: Tumor sólido · Cáncer de páncreas · Cáncer de mama · Cáncer avanzado · Cáncer metastásico.

Fase

Fase 1

Estado

Interrumpido

Participantes

5

previstos

Centros

3

Fin del objetivo primario

ago 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2013.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Business decision.».

Qué mide

Adverse events that are defined as dose limiting toxicities occurring in the first 21 days of treatment in Group 1 and the first 28 days of treatment in Group 2. (Approximately 21 days (Group 1); Approximately 28 days (Group 2)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de INCY

Todos los de INCY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01929941), actualizada en ene 2018.