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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03119467
• Other study ID #: RP4010-1601
• Status: Terminated
• Phase: Phase 1
• Start date: May 11, 2017
• Est. completion date: December 19, 2019

Study information

• Verified date: December 2019
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 19, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• RP4010
Escalating doses starting at 25 mg

Locations

Country	Name	City	State
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	Brisbane Clinic for Lymphoma, Myeloma and Leukaemia	Greenslopes	Queensland
Australia	Epworth HealthCare	Richmond	Victoria
Australia	St Vincent's Hospital	Sidney	New South Wales
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama	Birmingham	Alabama
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Utah Cancer Specialists	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) Determination	To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma	28 days
Secondary	Maximum Plasma Concentration (Cmax).	To assess the Maximum Plasma Concentration (Cmax).	24 hrs
Secondary	Area under the curve (AUC)	To assess the Area under the plasma concentration versus time curve (AUC)	24 hrs
Secondary	Anti-tumor activity-Overall response rate (ORR)	To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)	2 months