Clinical trial · Interventional
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
NCT03119467CI-TRIAL-00042491terminatedPhase 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): Study has been stopped after reviewing PK and safety results
Summary
Brief summary (as posted)
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP4010 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- RP4010 to be administered
- interventionNames
- Drug: RP4010
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) Determination
- timeFrame
- 28 days
- description
- To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Secondary outcomes (3)
- measure
- Maximum Plasma Concentration (Cmax).
- timeFrame
- 24 hrs
- description
- To assess the Maximum Plasma Concentration (Cmax).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory to or relapsed after at least 1 prior treatment line. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Patients must be ≥18 years of age * Able to give a written informed consent. Exclusion Criteria: * Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1). * Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection * Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months. * Patients with graft versus-host disease (GVHD) * Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity . * Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV); * Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec; * Patient with angina not well-controlled by medication; * Women who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.