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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03711578




Registration number
NCT03711578
Ethics application status
Date submitted
15/10/2018
Date registered
18/10/2018

Titles & IDs
Public title
Efficacy and Safety Study of Tenalisib (RP6530), a Novel PI3K d/? Dual Inhibitor in Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
Scientific title
An Open Label, Phase II Study to Evaluate the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K d/? Dual Inhibitor in Adult Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (iNHL)
Secondary ID [1] 0 0
RP6530-1802
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin 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 - Tenalisib,

Experimental: Tenalisib - Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles


Treatment: Drugs: Tenalisib,
BID, Orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
7 months
Primary outcome [2] 0 0
Complete Response Rate
Timepoint [2] 0 0
7 months
Primary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months
Primary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
7 months
Secondary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0
Timepoint [1] 0 0
8 months

Eligibility
Key inclusion criteria
1. Patients with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:

1. Follicular lymphoma (FL) G1, G2, or G3a
2. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
3. Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia (LPL/WM)
4. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5 x10^9/L at the time of diagnosis and at study entry.
2. Relapsed or refractory after = 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received rituximab and alkylating agents.
3. Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter = 1.5 cm.
4. Male or female patients > 18 years of age.
5. ECOG performance status = 2.
6. Life expectancy of at least 3 months.
7. Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:

1. Hemoglobin = 9 g/dl
2. Absolute neutrophil count (ANC) = 1 x 10^9/L
3. Platelets =50 x 10^9/L (patient without BM involvement) and 30 x 10^9/L (patient with BM involvement)
4. Total bilirubin =1.5 times the upper limit of normal (ULN)
5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN if known liver involvement
6. Creatinine = 1.5 mg/dL OR calculated creatinine clearance = 50 mL/min (as calculated by the Cockcroft-Gault method)
8. Use of an effective means of contraception for female patients of child-bearing potential, and all male partners.
9. Willingness and ability to comply with trial and follow-up procedures, give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. FL grade 3b or transformed disease or CLL
2. Cancer therapy within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D1. Corticosteroids (prednisone or equivalent) at a dose of < 20 mg daily are allowed. Corticosteroid should be stabilized for at least 1 week prior to C1D1
3. Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
4. History of having received an Allo-SCT
5. Active hepatitis B or C infection
6. Known history of human immunodeficiency virus (HIV) infection
7. Evidence of ongoing severe systemic bacterial, fungal or viral infection
8. Known primary central nervous system lymphoma or any preexisting neurologic manifestations
9. Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension;
10. Prior exposure to drug that specifically inhibits PI3K
11. Pregnancy or lactation
12. Myeloid growth factors or red blood cells/ platelet transfusion within 14 days prior to C1D1
13. Drug administration within 1 week prior to C1D1

1. Strong inhibitors or inducers of CYP3A4, CYP2C9, including grapefruit products, herbal supplements and drugs
2. Substrates of CYP3A4 enzyme with a narrow therapeutic range

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/10/2020
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Blacktown Hospital, Blacktown Cancer and Haematology Center - Blacktown
Recruitment hospital [2] 0 0
Brisbane Clinic for Lymphoma, Myeloma and Leukaemia, - Greenslopes,
Recruitment hospital [3] 0 0
John Flynn Private Hospital, - Tugun
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes,
Recruitment postcode(s) [3] 0 0
4224 - Tugun
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee

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)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03711578