Advertisement

Topics

A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma

2016-12-01 16:08:21 | BioPortfolio

Summary

The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma. The Phase 2 portion of the study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma or Lymphoma

Description

Background and Rationale:

• TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.

Phase 1:

Primary:

- To investigate the safety and tolerability of TAS4464

- To identify a tolerated dose of TAS4464

Secondary:

- To investigate the preliminary efficacy of TAS4464

- To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464

- To investigate the pharmacodynamics of TAS4464

Phase 2:

Primary:

• To investigate the efficacy of TAS4464

Secondary:

• To further investigate the safety profile of TAS4464

Study Design

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

Conditions

Multiple Myeloma

Intervention

TAS4464, Intravenous (IV) Infusion

Location

Boston
Massachusetts
United States

Status

Not yet recruiting

Source

Taiho Oncology, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:21-0500

Clinical Trials [2017 Associated Clinical Trials listed on BioPortfolio]

A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

The purpose of the study is to evaluate the safety, pharmacokinetics and antitumor activity of subcutaneous (SC) or intravenous (IV) delivery of daratumumab to participants with relapsed o...

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma

Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma

This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractor...

CART-BCMA Cells for Multiple Myeloma

Open-label, single-center, pilot study to assess the safety and feasibility of infusion of autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen receptor...

Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China

Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We want to compared the pharmacokinetic of subcu...

PubMed Articles [8802 Associated PubMed Articles listed on BioPortfolio]

Intravenous (IV) bortezomib infusion after non-response to subcutaneous bortezomib administration can induce transitory responses in multiple myeloma patients: are some patients more sensitive to IV bortezomib?

Polycythaemia: an unusual presentation of multiple myeloma.

In contrast to anaemia, polycythaemia is a distinctly uncommon finding in patients with multiple myeloma. We describe the presence of otherwise unexplained polycythaemia in a 57-year-old Caucasian man...

Infusion Rate Dependent Pharmacokinetics of Bendamustine with Altered Formation of γ-hydroxybendamustine (M3) Metabolite Following 30- and 60-min Infusion of Bendamustine in Rats.

Bendamustine is an alkylating agent administered as 1 h intravenous infusion in the clinic for the treatment of malignant haematological cancers. The aim of the study was to evaluate the pharmacokin...

Population Pharmacokinetics and Exposure-Response Relationship of Carfilzomib in Patients With Multiple Myeloma.

A population pharmacokinetic (PK) model and exposure-response (E-R) analysis was developed using data collected from 5 phase 1b/2 and 2 phase 3 studies in subjects with multiple myeloma. Subjects rece...

Engineered Nanoplatelets for Enhanced Treatment of Multiple Myeloma and Thrombus.

A platelet membrane-coated biomimetic nanocarrier, which can sequentially target bone microenvironment and myeloma cells to enhance the drug availability at the myeloma site and decrease the off-targe...

Medical and Biotech [MESH] Definitions

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

Fluid propulsion systems driven mechanically, electrically, or osmotically that are used to inject (or infuse) over time agents into a patient or experimental animal; used routinely in hospitals to maintain a patent intravenous line, to administer antineoplastic agents and other drugs in thromboembolism, heart disease, diabetes mellitus (INSULIN INFUSION SYSTEMS is also available), and other disorders.

Immunoglobulin preparations used in intravenous infusion, containing primarily IMMUNOGLOBULIN G. They are used to treat a variety of diseases associated with decreased or abnormal immunoglobulin levels including pediatric AIDS; primary HYPERGAMMAGLOBULINEMIA; SCID; CYTOMEGALOVIRUS infections in transplant recipients, LYMPHOCYTIC LEUKEMIA, CHRONIC; Kawasaki syndrome, infection in neonates, and IDIOPATHIC THROMBOCYTOPENIC PURPURA.

An imidazole antifungal agent that is used topically and by intravenous infusion.

More From BioPortfolio on "A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma"

Quick Search
Advertisement
 

Searches Linking to this Trial