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

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RP4010
Sponsored by
Rhizen Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama
  • City of Hope
  • University of Colorado
  • University of Michigan
  • Barbara Ann Karmanos Cancer Institute
  • University Hospitals Cleveland Medical Center
  • Utah Cancer Specialists
  • St Vincent's Hospital
  • Pindara Private Hospital
  • Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
  • Epworth HealthCare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

RP4010 to be administered

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2017
Last Updated
December 26, 2019
Sponsor
Rhizen Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT03119467
Brief Title
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Official Title
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Study has been stopped after reviewing PK and safety results
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhizen Pharmaceuticals SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
RP4010 to be administered
Intervention Type
Drug
Intervention Name(s)
RP4010
Intervention Description
Escalating doses starting at 25 mg
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) Determination
Description
To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax).
Description
To assess the Maximum Plasma Concentration (Cmax).
Time Frame
24 hrs
Title
Area under the curve (AUC)
Description
To assess the Area under the plasma concentration versus time curve (AUC)
Time Frame
24 hrs
Title
Anti-tumor activity-Overall response rate (ORR)
Description
To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
St Vincent's Hospital
City
Sidney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Epworth HealthCare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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