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

Phase 1

Terminated

• Conditions: Lymphoma
• Interventions: Drug: RP4010

• Registration Number: NCT03119467
• Lead Sponsor: Rhizen Pharmaceuticals SA

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Study Start: 2017-05-11
• Primary Completion: 2019-11-29
• Status Verified: 2019-12
• Study Completion: 2019-12-19
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	RP4010	RP4010 to be administered

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) Determination	28 days	To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax).	24 hrs	To assess the Maximum Plasma Concentration (Cmax).
Area under the curve (AUC)	24 hrs	To assess the Area under the plasma concentration versus time curve (AUC)
Anti-tumor activity-Overall response rate (ORR)	2 months	To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)

Trial Locations

Locations (11)

St Vincent's Hospital; 🇦🇺 Sidney, New South Wales, Australia

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

City of Hope; 🇺🇸 Duarte, California, United States

Brisbane Clinic for Lymphoma, Myeloma and Leukaemia; 🇦🇺 Greenslopes, Queensland, Australia

Pindara Private Hospital; 🇦🇺 Benowa, Queensland, Australia

Utah Cancer Specialists; 🇺🇸 Salt Lake City, Utah, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Epworth HealthCare; 🇦🇺 Richmond, Victoria, Australia