A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | March 1, 2017 |
End Date: | March 6, 2018 |
A Phase 1/2, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
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. The Phase 2 portion of the
study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma
or Lymphoma
appropriate dose for patients with Multiple Myeloma or Lymphoma. The Phase 2 portion of the
study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma
or Lymphoma
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
Phase 2:
Primary:
• To investigate the efficacy of TAS4464
Secondary:
• To further investigate the safety profile of TAS4464
• 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
Phase 2:
Primary:
• To investigate the efficacy of TAS4464
Secondary:
• To further investigate the safety profile of TAS4464
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
We found this trial at
7
sites
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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