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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02826642




Registration number
NCT02826642
Ethics application status
Date submitted
13/06/2016
Date registered
5/07/2016
Date last updated
16/01/2018

Titles & IDs
Public title
A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
Scientific title
A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
Secondary ID [1] 0 0
CIDH305X2102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IDH305

Experimental: Arm 1: Medically fit for induction - IDH305 + Standard of care for patients that are medically fit for induction.

Experimental: Arm 2 Medically unfit for induction - IDH305 + Standard of care for patients that are medically unfit for induction.


Treatment: Drugs: IDH305


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

Outcomes
Primary outcome [1] 0 0
Dose Limiting toxicities - (escalation only)
Timepoint [1] 0 0
10 months
Primary outcome [2] 0 0
Number of patients with adverse events (AEs)
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Area Under Curve (AUC) - To characterize the PK profile of IDH305 with SOC medications (each Arm)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Maximum Plasma Concentration (Cmax) - To characterize the PK profile of IDH305 with SOC medications (each Arm)
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Time taken to reach maximum plasma concentration (Tmax) - To characterize the PK profile of IDH305 with SOC medications (each Arm)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Complete remission rate (CRR) - To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Overall response rate (ORR) - To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Event free survival (EFS) - To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
Timepoint [6] 0 0
36 months

Eligibility
Key inclusion criteria
-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according
to rIPSS or equivalent) are also permitted in Arm 2.

- Documentation of IDH1R132 mutation of tumor

- ECOG performance status = 2

- Clinically fit for standard of care medication per protocol.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment for AML or MDS

- Any severe or uncontrolled medical conditions that would prevent the patient's
participation in the clinical study due to safety concerns or compliance with clinical
study procedures such as the presence of other clinically significant cardiac,
respiratory, gastrointestinal, renal, hepatic or neurological disease.

- Acute Promyelocytic Leukemia

- Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
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)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability and potential efficacy of
IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia
(AML).
Trial website
https://clinicaltrials.gov/show/NCT02826642
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02826642