Clinical trial NCT02381886: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Malignancies That Harbor IDHR132 Mutations
Keywords: IDHR132 mutations
IDH305
IDH
IDH1
AML
Acute Myeloid Leukemia
Leukemia
Myeloid
Acute
MDS
Myelodysplastic Syndrome
Glioma
Oligodendroglioma
Astrocytoma
Glioblastoma
Cholangiocarcinoma
Solid Tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incident rate of dose limiting toxicities (DLTs)
timeFrame: 21 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 30 months
measure: Plasma PK parameters (AUC, Cmax, Tmax)
timeFrame: 30 months
measure: Changes of 2-hydroxyglutarate concentration in patient specimens
timeFrame: 30 months
measure: Overall response rate (ORR)
timeFrame: 30 months
measure: Incidence of serious adverse events (SAE)
timeFrame: 30 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute SC (1)
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center- New York Presbyterian Onc Dept.
state: New York
city: Houston
country: United States
facility: Uni Of TX MD Anderson Cancer Cntr
state: Texas
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: ErasmusMC Cancer lnstitute, Neuro-Oncology, Rm G3-55
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: DiNardo CD, Hochhaus A, Frattini MG, Yee K, Zander T, Kramer A, Chen X, Ji Y, Parikh NS, Choi J, Wei AH. A phase 1 study of IDH305 in patients with IDH1R132-mutant acute myeloid leukemia or myelodysplastic syndrome. J Cancer Res Clin Oncol. 2023 Mar;149(3):1145-1158. doi: 10.1007/s00432-022-03983-6. Epub 2022 Mar 30.