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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

NCT00282399

Myelodysplastic Syndrome

TERMINATED PHASE1

Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)

NCT00067808

Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia

COMPLETED PHASE2

Tanespimycin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, or Myelodysplastic Syndromes

NCT00098423

Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Basophilic Leukemia Adult Acute Eosinophilic Leukemia +23 more

COMPLETED PHASE1

A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms

NCT04637009

Acute Myeloid Leukemia Myeloproliferative Neoplasm Myelodysplastic/Myeloproliferative Neoplasm

TERMINATED PHASE1

Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

NCT00941109

Myelodysplastic Syndrome

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma NonHodgkin Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAS4464

Group Type EXPERIMENTAL

TAS4464

Intervention Type DRUG

Intravenous (IV) Infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAS4464

Intravenous (IV) Infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provide written informed consent
2. Women of child-bearing potential must have a negative pregnancy test

Multiple Myeloma:

Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.

Lymphoma:

Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.

Exclusion Criteria

1. Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:

1. Major surgery within 28 days
2. Radiation/chemotherapy within 21 days
3. Monoclonal antibodies within 28 days
4. Corticosteroid administration \>20 mg/day of prednisone or equivalent within 14 days
5. Proteasome inhibitors within 14 days
6. Immunomodulatory agents within 7 days
7. Stem cell transplant within 3 months
8. Current immunosuppressive treatment for graft versus host disease
9. Current use of an investigational agent
2. Active graft versus host disease
3. Known serious illness or medical condition
4. Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
5. Pregnant or breast-feeding female

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No