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

Sponsor
Rhizen Pharmaceuticals SA (Industry)
Overall Status
Terminated
CT.gov ID
NCT03119467
Collaborator
(none)
21
Enrollment
11
Locations
1
Arm
31.3
Actual Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
Actual Study Start Date :
May 11, 2017
Actual Primary Completion Date :
Nov 29, 2019
Actual Study Completion Date :
Dec 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm

RP4010 to be administered

Drug: RP4010
Escalating doses starting at 25 mg

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Maximum Plasma Concentration (Cmax). [24 hrs]

    To assess the Maximum Plasma Concentration (Cmax).

  2. Area under the curve (AUC) [24 hrs]

    To assess the Area under the plasma concentration versus time curve (AUC)

  3. Anti-tumor activity-Overall response rate (ORR) [2 months]

    To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Rhizen Pharmaceuticals SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier:
NCT03119467
Other Study ID Numbers:
  • RP4010-1601
First Posted:
Apr 18, 2017
Last Update Posted:
Dec 27, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Dec 27, 2019