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

Description

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

Study Start Date

March, 01 2017

Estimated Completion Date

March 2022

Interventions

  • Drug: TAS4464

Study ID

Taiho Oncology, Inc. -- TAS-4464-101

Status

Recruiting

Trial ID

NCT02978235

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

243

Sponsor

Taiho Oncology, Inc.

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (11)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles None None None
Center for Cancer and Blood Disorders - Bethesda, Maryland 394.0 miles None None None
Gabrail Cancer Center - Canton, Ohio 545.3 miles None None None
Weisberg Cancer Treatment Center - Farmington Hills, Michigan 625.6 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles None None None

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