Description:
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132
mutations.
Title
- Brief Title: A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
- Official Title: A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Clinical Trial IDs
- ORG STUDY ID:
CIDH305X2101
- NCT ID:
NCT02381886
Conditions
- Advanced Malignancies That Harbor IDHR132 Mutations
Interventions
| Drug | Synonyms | Arms |
|---|
| IDH305 | | IDH305 |
Purpose
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132
mutations.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| IDH305 | Experimental | | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Incident rate of dose limiting toxicities (DLTs) |
| Time Frame: | 21 days |
| Safety Issue: | |
| Description: | To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE) |
Secondary Outcome Measures
| Measure: | Incidence of adverse events (AEs) |
| Time Frame: | 30 months |
| Safety Issue: | |
| Description: | To characterize the safety and tolerability of IDH305 |
| Measure: | Plasma PK parameters (AUC, Cmax, Tmax) |
| Time Frame: | 30 months |
| Safety Issue: | |
| Description: | To characterize the PK profile of IDH305 |
| Measure: | Changes of 2-hydroxyglutarate concentration in patient specimens |
| Time Frame: | 30 months |
| Safety Issue: | |
| Description: | To characterize the PD profile of IDH305 |
| Measure: | Overall response rate (ORR) |
| Time Frame: | 30 months |
| Safety Issue: | |
| Description: | To assess any preliminary anti-tumor activity of IDH305 |
| Measure: | Incidence of serious adverse events (SAE) |
| Time Frame: | 30 months |
| Safety Issue: | |
| Description: | To characterize the safety and tolerability of IDH305 |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- IDHR132 mutations
- IDH305
- IDH
- IDH1
- AML
- Acute Myeloid Leukemia
- Leukemia
- Myeloid
- Acute
- MDS
- Myelodysplastic Syndrome
- Glioma
- Oligodendroglioma
- Astrocytoma
- Glioblastoma
- Cholangiocarcinoma
- Solid Tumors
Last Updated
July 26, 2021
