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

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ClinicalTrials.gov Identifier: NCT03119467
Recruitment Status : Terminated (Study has been stopped after reviewing PK and safety results)
First Posted : April 18, 2017
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Study Description
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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
Lymphoma Drug: RP4010 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
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Study Type : Interventional  (Clinical Trial)
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 : November 29, 2019
Actual Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
RP4010 to be administered
 Drug: RP4010
Escalating doses starting at 25 mg


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) Determination [ Time Frame: 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). [ Time Frame: 24 hrs ]
    To assess the Maximum Plasma Concentration (Cmax).

  2. Area under the curve (AUC) [ Time Frame: 24 hrs ]
    To assess the Area under the plasma concentration versus time curve (AUC)

  3. Anti-tumor activity-Overall response rate (ORR) [ Time Frame: 2 months ]
    To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119467


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-3300
United States, California
City of Hope
Duarte, California, United States, 91010
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Australia, New South Wales
St Vincent's Hospital
Sidney, New South Wales, Australia, 2010
Australia, Queensland
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes, Queensland, Australia, 4120
Australia, Victoria
Epworth HealthCare
Richmond, Victoria, Australia, 3121
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
More Information
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT03119467    
Other Study ID Numbers: RP4010-1601
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases