Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas

Rhizen Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Lymphoma

Treatments

Drug: RP4010

Study type

Interventional

Funder types

Industry

Identifiers

NCT03119467

RP4010-1601

Details and patient eligibility

About

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).

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.