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

• Status: Terminated
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhizen Pharmaceuticals SA

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.