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TERMINATEDPhase 1NCT03119467

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

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

Lead sponsor: Rhizen Pharmaceuticals SA•7 U.S. locations•View source on ClinicalTrials.gov

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What this study is about

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Sponsors

Lead Sponsor

Rhizen Pharmaceuticals SA

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).

Age

18 - No limit years

Sex

ALL

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 27, 2019Terms

Trial snapshot

StatusTERMINATED

PhasePHASE1

Enrollment21

Start dateMay 2017

Last updatedDec 27, 2019

Condition

Locations shown

University of Alabama

Birmingham, Alabama

City of Hope

Duarte, California

University of Colorado

Aurora, Colorado

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2019Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions