A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
1 other identifier
interventional
N/A
0 countries
N/A
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2016
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedStudy Start
First participant enrolled
August 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2016
CompletedApril 10, 2019
April 1, 2019
3 months
June 13, 2016
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Limiting toxicities
(escalation only)
10 months
Number of patients with adverse events (AEs)
36 months
Secondary Outcomes (6)
Area Under Curve (AUC)
36 months
Maximum Plasma Concentration (Cmax)
36 months
Time taken to reach maximum plasma concentration (Tmax)
36 months
Complete remission rate (CRR)
36 months
Overall response rate (ORR)
36 months
- +1 more secondary outcomes
Study Arms (2)
Arm 1: Medically fit for induction
EXPERIMENTALIDH305 + Standard of care for patients that are medically fit for induction.
Arm 2 Medically unfit for induction
EXPERIMENTALIDH305 + Standard of care for patients that are medically unfit for induction.
Interventions
Eligibility Criteria
You may qualify if:
- \-- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2016
First Posted
July 11, 2016
Study Start
August 26, 2016
Primary Completion
November 29, 2016
Study Completion
November 29, 2016
Last Updated
April 10, 2019
Record last verified: 2019-04