Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Purpose
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
Condition
- Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single arm |
RP4010 to be administered |
|
More Details
- Status
- Terminated
- Sponsor
- Rhizen Pharmaceuticals SA
Study Contact
Detailed Description
Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT). Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).