Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This trial is evaluating the safety, pharmacokinetics and efficacy of RP4014, to be administered at escalating doses starting at 25 mg. This trial has a single group assignment.
Conditions
This trial is treating people with Lymphoma
Eligibility
Inclusion
- 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
- 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.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Rhizen Pharmaceuticals SA
Scientific Title
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
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