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A Phase 1, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 in Subjects With Previously Treated B-Cell Malignancies

2014-10-01 16:53:22 | BioPortfolio

Summary

Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, INCB050465. INCB050465 inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

B-Cell Malignancies

Intervention

INCB050465

Location

New York
New York
United States

Status

Not yet recruiting

Source

Incyte Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-10-01T16:53:22-0400

Clinical Trials [620 Associated Clinical Trials listed on BioPortfolio]

A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of INCB050465 in the treatment of Japanese participants diagnosed with previously-treated B-cell lym...

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 INCB050465 treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (...

A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

The purpose of this study is to evaluate the safety and tolerability of INCB050465 when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or r...

An Open-Label, Randomized Study Comparing INCB050465 to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

The purpose of this study is to assess the objective response rate with INCB050465 treatment compared to idelalisib treatment in subjects with relapsed or refractory follicular lymphoma.

PubMed Articles [16098 Associated PubMed Articles listed on BioPortfolio]

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Targeting Bruton's tyrosine kinase for the treatment of B cell associated malignancies and autoimmune diseases: Preclinical and clinical developments of small molecule inhibitors.

B cell receptor (BCR) signaling plays a key role in B cell development and function. Aberrant BCR signaling has been confirmed as a central driver for the pathogenesis of various B cell malignancies. ...

Association Between Renal Cell Carcinoma and Myelodysplastic Syndromes: Epigenetic Underpinning?

Renal cell carcinoma (RCC) and certain myeloid malignancies are both characterized by widespread aberrant DNA hypermethylation. After clinical observations of patients with a personal history of both ...

Human Herpes Virus 8 in HIV-1 infected individuals receiving cancer chemotherapy and stem cell transplantation.

Human Herpes Virus 8 (HHV8) can cause Kaposi's Sarcoma (KS) in immunosuppressed individuals. However, little is known about the association between chemotherapy or hematopoietic stem cell transplantat...

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At our institution, we noted that children with hematological malignancies and solid tumors often suffered from ingrown toenails (IGTNs) during hospitalization for chemotherapy and stem cell transplan...

Medical and Biotech [MESH] Definitions

A strain of PRIMATE T-LYMPHOTROPIC VIRUS 1 isolated from mature T4 cells in patients with T-lymphoproliferation malignancies. It causes adult T-cell leukemia (LEUKEMIA-LYMPHOMA, T-CELL, ACUTE, HTLV-I-ASSOCIATED), T-cell lymphoma (LYMPHOMA, T-CELL), and is involved in mycosis fungoides, SEZARY SYNDROME and tropical spastic paraparesis (PARAPARESIS, TROPICAL SPASTIC).

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A neoplasm composed entirely of GRANULOSA CELLS, occurring mostly in the OVARY. In the adult form, it may contain some THECA CELLS. This tumor often produces ESTRADIOL and INHIBIN. The excess estrogen exposure can lead to other malignancies in women and PRECOCIOUS PUBERTY in girls. In rare cases, granulosa cell tumors have been identified in the TESTES.

A potent inhibitor of ADENOSINE DEAMINASE. The drug induces APOPTOSIS of LYMPHOCYTES, and is used in the treatment of many lymphoproliferative malignancies, particularly HAIRY CELL LEUKEMIA. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.

Cellular DNA-binding proteins encoded by the myb gene (GENES, MYB). They are expressed in a wide variety of cells including thymocytes and lymphocytes, and regulate cell differentiation. Overexpression of myb is associated with autoimmune diseases and malignancies.

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