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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03119467




Registration number
NCT03119467
Ethics application status
Date submitted
10/04/2017
Date registered
18/04/2017
Date last updated
8/08/2019

Titles & IDs
Public title
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Scientific title
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
Secondary ID [1] 0 0
RP4010-1601
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RP4010

Experimental: Single arm - RP4010 to be administered


Treatment: Drugs: RP4010
Escalating doses starting at 25 mg

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) Determination - To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax). - To assess the Maximum Plasma Concentration (Cmax).
Timepoint [1] 0 0
24 hrs
Secondary outcome [2] 0 0
Area under the curve (AUC) - To assess the Area under the plasma concentration versus time curve (AUC)
Timepoint [2] 0 0
24 hrs
Secondary outcome [3] 0 0
Anti-tumor activity-Overall response rate (ORR) - To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR)
Timepoint [3] 0 0
2 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sidney
Recruitment hospital [2] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [3] 0 0
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia - Greenslopes
Recruitment hospital [4] 0 0
Epworth HealthCare - Richmond
Recruitment postcode(s) [1] 0 0
2010 - Sidney
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Rhizen Pharmaceuticals SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or
Refractory Lymphomas
Trial website
https://clinicaltrials.gov/show/NCT03119467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Prajak Barde, MD
Address 0 0
Country 0 0
Phone 0 0
+41 32 580 0113
Fax 0 0
Email 0 0
pjb@rhizen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03119467