Clinical trial · Interventional
A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
NCT02978235CI-TRIAL-00080457terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| NonHodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS4464 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS4464
- interventionNames
- Drug: TAS4464
Primary outcomes (2)
- measure
- 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
- timeFrame
- Completion of Cycle 1 (28 days)
- measure
- 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
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.