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

Sponsor

Taiho Oncology, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02978235

Collaborator

(none)

Enrollment

Locations

Arm

11.1

Actual Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma NonHodgkin Lymphoma	Drug: TAS4464	Phase 1

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAS4464	Drug: TAS4464 Intravenous (IV) Infusion

Arm

Intervention/Treatment

Experimental: TAS4464

Drug: TAS4464

Intravenous (IV) Infusion

Outcome Measures

Primary Outcome Measures

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)]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provide written informed consent
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:

Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
Major surgery within 28 days
Radiation/chemotherapy within 21 days
Monoclonal antibodies within 28 days
Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days
Proteasome inhibitors within 14 days
Immunomodulatory agents within 7 days
Stem cell transplant within 3 months
Current immunosuppressive treatment for graft versus host disease
Current use of an investigational agent
Active graft versus host disease
Known serious illness or medical condition
Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
Pregnant or breast-feeding female

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20817
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
3	Weisberg Cancer Treatment Center	Farmington Hills	Michigan	United States	48334
4	Mayo Clinic	Rochester	Minnesota	United States	55905
5	John Theurer Cancer Center at Hackensack Meridian Health	Hackensack	New Jersey	United States	07601
6	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
7	Gabrail Cancer Center	Canton	Ohio	United States	44718