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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03119467
Ethics application status
Date submitted
10/04/2017
Date registered
18/04/2017

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
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax).
Timepoint [1] 0 0
24 hrs
Secondary outcome [2] 0 0
Area under the curve (AUC)
Timepoint [2] 0 0
24 hrs
Secondary outcome [3] 0 0
Anti-tumor activity-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
Sex
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
NA
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2019
Sample size
Target
Accrual to date
Final
21
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03119467