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

Taiho Pharma

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma; NonHodgkin Lymphoma

Treatments: Drug: TAS4464

Study type: Interventional

Funder types: Industry

Identifiers

NCT02978235

TAS-4464-101

Details and patient eligibility

About

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.

Full description

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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

TAS4464

Experimental group

Treatment:

Drug: TAS4464