Purpose

A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas

Condition

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

ArmDescriptionAssigned Intervention
Experimental
Single arm
RP4010 to be administered
  • Drug: RP4010
    Escalating doses starting at 25 mg

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.