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

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

Study Overview

• Status: Terminated
• Conditions: Lymphoma
• Intervention / Treatment: Drug: RP4010

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sidney, New South Wales, Australia, 2010
      • St Vincent's Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
    • Greenslopes, Queensland, Australia, 4120
      • Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
  • Victoria
    • Richmond, Victoria, Australia, 3121
      • Epworth HealthCare
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • University of Alabama
  • California
    • Duarte, California, United States, 91010
      • City of Hope
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; RP4010 to be administered	Drug: RP4010; Escalating doses starting at 25 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rhizen Pharmaceuticals SA

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): November 29, 2019
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: RP4010-1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No