Advanced Malignancies That Harbor IDHR132 Mutations
Conditions
Keywords
IDHR132 mutations, IDH305, IDH, IDH1, AML, Acute Myeloid Leukemia, Leukemia, Myeloid, Acute, MDS, Myelodysplastic Syndrome, Glioma, Oligodendroglioma, Astrocytoma, Glioblastoma, Cholangiocarcinoma, Solid Tumors
Brief summary
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.
Interventions
DRUGIDH305
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Documented IDH1R132-mutant tumors * ECOG performance status ≤ 2
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident rate of dose limiting toxicities (DLTs) | 21 days | To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | 30 months | To characterize the safety and tolerability of IDH305 |
| Plasma PK parameters (AUC, Cmax, Tmax) | 30 months | To characterize the PK profile of IDH305 |
| Changes of 2-hydroxyglutarate concentration in patient specimens | 30 months | To characterize the PD profile of IDH305 |
| Overall response rate (ORR) | 30 months | To assess any preliminary anti-tumor activity of IDH305 |
| Incidence of serious adverse events (SAE) | 30 months | To characterize the safety and tolerability of IDH305 |
Countries
Australia, Belgium, Canada, Germany, Netherlands, Singapore, Spain, United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed