Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03755154
Registration number
NCT03755154
Ethics application status
Date submitted
13/11/2018
Date registered
27/11/2018
Date last updated
22/03/2024
Titles & IDs
Public title
Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
Query!
Scientific title
Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
Query!
Secondary ID [1]
0
0
2018-004170-97
Query!
Secondary ID [2]
0
0
CL1-65487-002
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Acute Myeloid Leukemia
0
0
Query!
Relapsed or Refractory Non-Hodgkin Lymphoma
0
0
Query!
Relapsed or Refractory Multiple Myeloma
0
0
Query!
Relapsed or Refractory Chronic Lymphocytic Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - S65487- initial scheme
Treatment: Drugs - S65487 - alternative scheme
Experimental: S65487 - initial scheme -
Experimental: S65487 - alternative scheme -
Treatment: Drugs: S65487- initial scheme
S65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle.
Treatment: Drugs: S65487 - alternative scheme
S65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence of Dose Limiting Toxicity (DLT)
Query!
Assessment method [1]
0
0
Safety criterion
Query!
Timepoint [1]
0
0
until the end of the first cycle (each cycle is 21days)
Query!
Primary outcome [2]
0
0
Incidence and severity of Adverse Events
Query!
Assessment method [2]
0
0
Safety and tolerability criteria
Query!
Timepoint [2]
0
0
through study completion an average of 6 months
Query!
Primary outcome [3]
0
0
Incidence and severity of Serious Adverse Events
Query!
Assessment method [3]
0
0
Safety and tolerability criteria
Query!
Timepoint [3]
0
0
through study completion an average of 6 months
Query!
Primary outcome [4]
0
0
Number of participants with dose reductions
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
through study completion an average of 6 months
Query!
Primary outcome [5]
0
0
Number of participants with dose interruptions
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
through study completion an average of 6 months
Query!
Primary outcome [6]
0
0
Dose intensity
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
through study completion an average of 6 months
Query!
Secondary outcome [1]
0
0
The pharmacokinetic (PK) profile of S65487: Area Under the Curve (AUC)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Query!
Secondary outcome [2]
0
0
PK profile of S65487: Volume of distribution at steady-state (Vss)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Query!
Secondary outcome [3]
0
0
PK profile of S65487: total CLearance (CL)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Query!
Secondary outcome [4]
0
0
PK profile of S65487: terminal half-life (t½z)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Query!
Secondary outcome [5]
0
0
Best Overall Response (BOR)
Query!
Assessment method [5]
0
0
Best Response observed during the treatment period
Query!
Timepoint [5]
0
0
Through study completion, an average of 6 months
Query!
Secondary outcome [6]
0
0
Overall Response Rate (ORR)
Query!
Assessment method [6]
0
0
Proportion of patients in whom a complete response (CR) or a partial response (PR)
Query!
Timepoint [6]
0
0
Through study completion, an average of 6 months
Query!
Eligibility
Key inclusion criteria
- Patients with cytologically confirmed and documented de novo, secondary or
therapy-related AML, excluding acute promyelocytic leukaemia with relapsed or
refractory disease without established alternative therapy. Or patients with
measurable confirmed Multiple Myeloma (IMWG) with relapsed or refractory disease who
have previously received at least three lines of treatment and without established
alternative therapy. Or patients with histologically and measurable confirmed Non
Hodgkin Lymphoma defined as Diffuse Large B cell Lymphoma (DLBCL), Follicular Lymphoma
(FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), High-Grade B cell
Lymphoma with relapsed or refractory disease who have received at least two lines of
therapy (including rituximab) and without established alternative therapy. Or patients
with Chronic Lymphocytic Leukemia (CLL) who have relapsed or are refractory (except
treatment failure), as defined per iwCLL, from venetoclax treatment and without
established alternative therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status = 2.
- For NHL, MM patients and CLL patients: haematological function (independent of any
growth factor support) based on the last assessment performed before inclusion,
defined as: absolute neutrophil count (ANC) = 1 x 109/L, haemoglobin = 8 g/dL,
platelet count = 50 x 109/L for NHL and MM patients, platelet count = 30 x 109/L for
CLL patients.
- For AML patients: circulating Blood White Cell count (WBC count) < 25 x 109/L (with or
without use of hydroxycarbamide/leukapheresis) based on the last assessment performed
before inclusion.
- Adequate renal function based on the last assessment performed before inclusion,
assessed as Glomerular Filtration Rate (GFR) using Modification of Diet in Renal
Disease (MDRD) Formula.
- Adequate hepatic function based on the last assessment performed before inclusion.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- Participation in another interventional study at the same time or another
interventional study requiring investigational treatment intake within 3 weeks or at
least 5 half-lives (whichever is longer) prior to the first S65487 administration.
- Participant already enrolled in the study (informed consent signed) and has received
at least one dose of S65487.
- Patients who have not recovered from toxicity of previous anticancer therapy,
including grade = 2 non-hematologic toxicity, prior to the first IMP administration
(including peripheral neurotoxicity). Certain toxicities will not be considered in
this category (e.g. alopecia).
- Patients refractory to a previous treatment with a Bcl-2 inhibitor.
- For AML patients : Allogenic stem cell transplant within 3 months before the first IMP
administration and/or patients who still receive immunosuppressive treatment within 3
months before the first IMP administration and/or patients with active
Graft-versus-host disease within 3 months before the first IMP administration and/or
patient who receive donor lymphocyte infusion (DLI) within 3 months before the first
IMP administration.
- For NHL, MM and CLL patients : Prior allogenic stem cell transplant before the first
IMP administration and/or Autologous stem cell transplant within 3 months before the
first IMP administration.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/07/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/11/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
60
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
France
Query!
State/province [1]
0
0
Lille
Query!
Country [2]
0
0
France
Query!
State/province [2]
0
0
Nantes
Query!
Country [3]
0
0
France
Query!
State/province [3]
0
0
Nice
Query!
Country [4]
0
0
Spain
Query!
State/province [4]
0
0
Madrid
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Pamplona
Query!
Country [6]
0
0
Spain
Query!
State/province [6]
0
0
Salamanca
Query!
Country [7]
0
0
Spain
Query!
State/province [7]
0
0
Valencia
Query!
Country [8]
0
0
United Kingdom
Query!
State/province [8]
0
0
London
Query!
Country [9]
0
0
United Kingdom
Query!
State/province [9]
0
0
Manchester
Query!
Country [10]
0
0
United Kingdom
Query!
State/province [10]
0
0
Newcastle
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Institut de Recherches Internationales Servier
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
ADIR, a Servier Group company
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic
(PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/
Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously
(i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML),
Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03755154
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03755154
Download to PDF