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BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)

2019-07-18 10:31:13 | BioPortfolio

Summary

This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia and Phase Ib).

The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RDE) of BR101801 in patients with relapsed/refractory advanced hematologic malignancies except acute leukemia and multiple myeloma.

The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory hematologic malignances at a dose of BR101801 identified in Phase Ia. Once the RDE has been determined in Phase Ia (dose escalation), Phase Ib (dose expansion) will commence, and 3 groups will be recruited in parallel.

Description

1. Phase Ia (Dose Escalation)

Primary Objectives

- To assess the safety and tolerability of BR101801 in patients with relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL.

- To assess DLT and to determine the MTD and/or the RDE dose for BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression.

SecondaryObjectives

- To characterize the plasma and urine PK of BR101801.

- To assess the preliminary antitumor activity of BR101801.

Exploratory Objectives

- To characterize the PD of BR101801.

- To explore BR101801 metabolites.

2. Phase Ib (Dose Expansion)

Primary Objectives

•To assess the safety and tolerability of BR101801 at the RDE dose in patients with relapsed and/or refractory B-cell lymphoma, CLL/SLL, and PTCL.

SecondaryObjectives

- To assess clinical activity of BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression.

- To assess the plasma PK of BR101801

Exploratory Objectives

- To assess the PD of BR101801.

- To explore BR101801 metabolites.

OUTLINE:This is a Phase I, multi-center, open-label, FIH study . Patients in Phase Ia and Phase Ib will receive BR101801 capsules orally and safety monitoring committee (SMC) will be responsible for safety oversight.

Study Design

Conditions

Diffuse Large B Cell Lymphoma

Intervention

BR101801 (Phase Ia), BR101801 (Phase Ib)

Status

Not yet recruiting

Source

Boryung Pharmaceutical Co., Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-18T10:31:13-0400

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Medical and Biotech [MESH] Definitions

The period of the CELL CYCLE following DNA synthesis (S PHASE) and preceding M PHASE (cell division phase). The CHROMOSOMES are tetraploid in this point.

The complex series of phenomena, occurring between the end of one CELL DIVISION and the end of the next, by which cellular material is duplicated and then divided between two daughter cells. The cell cycle includes INTERPHASE, which includes G0 PHASE; G1 PHASE; S PHASE; and G2 PHASE, and CELL DIVISION PHASE.

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