Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
NCT ID: NCT03119467
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2017-05-11
2019-12-19
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
RP4010 to be administered
RP4010
Escalating doses starting at 25 mg
Interventions
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RP4010
Escalating doses starting at 25 mg
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Rhizen Pharmaceuticals SA
INDUSTRY
Responsible Party
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Locations
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University of Alabama
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of Colorado
Aurora, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
St Vincent's Hospital
Sydney, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
Greenslopes, Queensland, Australia
Epworth HealthCare
Richmond, Victoria, Australia
Countries
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Other Identifiers
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RP4010-1601
Identifier Type: -
Identifier Source: org_study_id