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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02381886




Registration number
NCT02381886
Ethics application status
Date submitted
2/03/2015
Date registered
6/03/2015

Titles & IDs
Public title
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Scientific title
A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Secondary ID [1] 0 0
CIDH305X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Malignancies That Harbor IDHR132 Mutations 0 0
Condition category
Condition code

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

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incident rate of dose limiting toxicities (DLTs)
Timepoint [1] 0 0
21 days
Secondary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
30 months
Secondary outcome [2] 0 0
Plasma PK parameters (AUC, Cmax, Tmax)
Timepoint [2] 0 0
30 months
Secondary outcome [3] 0 0
Changes of 2-hydroxyglutarate concentration in patient specimens
Timepoint [3] 0 0
30 months
Secondary outcome [4] 0 0
Overall response rate (ORR)
Timepoint [4] 0 0
30 months
Secondary outcome [5] 0 0
Incidence of serious adverse events (SAE)
Timepoint [5] 0 0
30 months

Eligibility
Key inclusion criteria
* Documented IDH1R132-mutant tumors
* ECOG performance status = 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
* 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
Not applicable
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/10/2025
Actual
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Germany
State/province [6] 0 0
Heidelberg
Country [7] 0 0
Germany
State/province [7] 0 0
Jena
Country [8] 0 0
Germany
State/province [8] 0 0
Koeln
Country [9] 0 0
Netherlands
State/province [9] 0 0
Rotterdam
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Spain
State/province [11] 0 0
Catalunya

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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?

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/NCT02381886