A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
- Registration Number
- NCT02978235
- Lead Sponsor
- Taiho Oncology, Inc.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAS4464 TAS4464 -
- Primary Outcome Measures
Name Time Method 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 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Weisberg Cancer Treatment Center
🇺🇸Farmington Hills, Michigan, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
John Theurer Cancer Center at Hackensack Meridian Health
🇺🇸Hackensack, New Jersey, United States