A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Advanced Malignancies That Harbor IDHR132 Mutations Clinical Trial

Official title:

A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02381886
• Other study ID #: CIDH305X2101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 6, 2015
• Est. completion date: October 24, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 166
• Est. completion date: October 24, 2025
• Est. primary completion date: December 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Malignancies That Harbor IDHR132 Mutations
• Neoplasms

Intervention

Drug:
• IDH305

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Parkville	Victoria
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Toronto	Ontario
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Koeln
Netherlands	ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55	Rotterdam
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
United States	Dana Farber Cancer Institute SC (1)	Boston	Massachusetts
United States	Uni of TX MD Anderson Cancer Cntr .	Houston	Texas
United States	Columbia University Medical Center- New York Presbyterian Onc Dept.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Netherlands,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident rate of dose limiting toxicities (DLTs)	To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)	21 days
Secondary	Incidence of adverse events (AEs)	To characterize the safety and tolerability of IDH305	30 months
Secondary	Plasma PK parameters (AUC, Cmax, Tmax)	To characterize the PK profile of IDH305	30 months
Secondary	Changes of 2-hydroxyglutarate concentration in patient specimens	To characterize the PD profile of IDH305	30 months
Secondary	Overall response rate (ORR)	To assess any preliminary anti-tumor activity of IDH305	30 months
Secondary	Incidence of serious adverse events (SAE)	To characterize the safety and tolerability of IDH305	30 months