NCT02978235

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

November 21, 2016

Last Update Submit

August 30, 2024

Conditions

Multiple MyelomaNonHodgkin Lymphoma

Keywords

Multiple MyelomaRelapsed/RefractoryLymphomaNon-Hodgkin LymphomaDiffuse Large B-Cell LymphomaDLBCLMantle Cell LymphomaMCLPeripheral T-Cell LymphomaPTCLTAS4464NEDD8NAE inhibitorNeoplasmsHematologic DiseasesMyeloma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

TAS4464

EXPERIMENTAL
Drug: TAS4464

Interventions

TAS4464DRUG

Intravenous (IV) Infusion

TAS4464

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

John Theurer Cancer Center at Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Multiple MyelomaLymphoma, Non-HodgkinRecurrenceLymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, T-Cell, PeripheralNeoplasmsHematologic DiseasesNeoplasms, Plasma Cell

Interventions

TAS4464

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, T-Cell

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 30, 2016

Study Start

March 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

September 5, 2024

Record last verified: 2024-08

Locations

US(7)