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

Stopped early · Phase 1

Conditions studied: Lymphoma

In brief

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

Key facts

Study ID

NCT03119467

Run by

Rhizen Pharmaceuticals SA

People needed

21

Starts

2017-05-11

Expected to finish

2019-12-19

Last updated by the study team

2019-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• City of Hope — Duarte, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• St Vincent's Hospital — Sydney, New South Wales, Australia
• Pindara Private Hospital — Benowa, Queensland, Australia
• Brisbane Clinic for Lymphoma, Myeloma and Leukaemia — Greenslopes, Queensland, Australia
• Epworth HealthCare — Richmond, Victoria, Australia

Full record on ClinicalTrials.gov

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