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

Multiple Myeloma Clinical Trial

Official title:

A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02978235
• Other study ID #: TAS-4464-101
• Status: Terminated
• Phase: Phase 1
• Start date: March 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: June 2021
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• NonHodgkin Lymphoma

Intervention

Drug:
• TAS4464
Intravenous (IV) Infusion

Locations

Country	Name	City	State
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Gabrail Cancer Center	Canton	Ohio
United States	Weisberg Cancer Treatment Center	Farmington Hills	Michigan
United States	John Theurer Cancer Center at Hackensack Meridian Health	Hackensack	New Jersey
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures		Completion of Cycle 1 (28 days)
Primary	Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results		Up to 5 years