Non Hodgkin Lymphoma Clinical Trial

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

Summary

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

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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).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

21

Study ID:

NCT03119467

Recruitment Status:

Terminated

Sponsor:

Rhizen Pharmaceuticals SA

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There are 11 Locations for this study

See Locations Near You

University of Alabama
Birmingham Alabama, 35294, United States
City of Hope
Duarte California, 91010, United States
University of Colorado
Aurora Colorado, 80045, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
St Vincent's Hospital
Sidney New South Wales, 2010, Australia
Pindara Private Hospital
Benowa Queensland, 4217, Australia
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes Queensland, 4120, Australia
Epworth HealthCare
Richmond Victoria, 3121, Australia

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

21

Study ID:

NCT03119467

Recruitment Status:

Terminated

Sponsor:


Rhizen Pharmaceuticals SA

How clear is this clinincal trial information?

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