Back to resultsA Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
Primary Purpose
Multiple Myeloma, NonHodgkin Lymphoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAS4464
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed/Refractory, Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, Mantle Cell Lymphoma, MCL, Peripheral T-Cell Lymphoma, PTCL, TAS4464, NEDD8, NAE inhibitor, Neoplasms, Hematologic Diseases, Myeloma
Eligibility Criteria
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
Sites / Locations
- Center for Cancer and Blood Disorders
- Dana-Farber Cancer Institute
- Weisberg Cancer Treatment Center
- Mayo Clinic
- John Theurer Cancer Center at Hackensack Meridian Health
- Icahn School of Medicine at Mount Sinai
- Gabrail Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAS4464
Arm Description
Outcomes
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02978235
Brief Title
A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
Official Title
A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
The trial was put on Clinical Hold and subsequently terminated prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, NonHodgkin Lymphoma
Keywords
Multiple Myeloma, Relapsed/Refractory, Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, Mantle Cell Lymphoma, MCL, Peripheral T-Cell Lymphoma, PTCL, TAS4464, NEDD8, NAE inhibitor, Neoplasms, Hematologic Diseases, Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAS4464
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAS4464
Intervention Description
Intravenous (IV) Infusion
Primary Outcome Measure Information:
Title
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
Time Frame
Completion of Cycle 1 (28 days)
Title
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
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack Meridian Health
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
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