Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: RP4010 | Phase 1 |
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 (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 |
Arm | Intervention/treatment |
---|---|
Experimental: Single arm
RP4010 to be administered
|
Drug: RP4010
Escalating doses starting at 25 mg |
- 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
- Maximum Plasma Concentration (Cmax). [ Time Frame: 24 hrs ]To assess the Maximum Plasma Concentration (Cmax).
- Area under the curve (AUC) [ Time Frame: 24 hrs ]To assess the Area under the plasma concentration versus time curve (AUC)
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

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