Clinical trial · Interventional
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma
NCT01199718CI-TRIAL-00005017unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CX-4945 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CX-4945
- description
- CX-4945 oral formulation
- interventionNames
- Drug: CX-4945
Primary outcomes (1)
- measure
- Safety
- timeFrame
- One year (assessed at Cycle 1).
- description
- Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
Secondary outcomes (3)
- measure
- Pharmacokinetic and pharmacodynamic assessments.
- timeFrame
- One year - assessed throughout all cycles of participation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females at least 18 years of age * Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy. * Measureable disease. * Karnofsky Performance Status at least 60% * Adequate liver and renal function and hematology laboratory values * Female patients of child-bearing potential must have a negative pregnancy test. * Signed informed consent. Exclusion Criteria: * Treatment with systemic cancer therapy within 21 days before screening. * Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug. * Grade 3 sensory neuropathy or motor neuropathy with pain * Concurrent severe or uncontrolled medical disease. * Active systemic fungal, bacterial, and/or viral infection. * Difficulty with swallowing, or an active malabsorption syndrome. * Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis. * History of gastric or small bowel surgery. * Pregnant or nursing females.
References
Publications (0)
Data not yet available
No reference posted for this study.