Non Hodgkin Lymphoma Clinical Trial
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Summary
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
Full 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).
Eligibility Criteria
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.
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There are 11 Locations for this study
Birmingham Alabama, 35294, United States
Duarte California, 91010, United States
Aurora Colorado, 80045, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Cleveland Ohio, 44106, United States
Salt Lake City Utah, 84106, United States
Sidney New South Wales, 2010, Australia
Benowa Queensland, 4217, Australia
Greenslopes Queensland, 4120, Australia
Richmond Victoria, 3121, Australia
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