A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02826642
• Other study ID #: CIDH305X2102
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 26, 2016
• Est. completion date: November 29, 2016

Study information

• Verified date: April 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 29, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-- 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.

Exclusion Criteria:

• 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

Other protocol-defined Inclusion/Exclusion may apply

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• IDH305

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting toxicities	(escalation only)	10 months
Primary	Number of patients with adverse events (AEs)		36 months
Secondary	Area Under Curve (AUC)	To characterize the PK profile of IDH305 with SOC medications (each Arm)	36 months
Secondary	Maximum Plasma Concentration (Cmax)	To characterize the PK profile of IDH305 with SOC medications (each Arm)	36 months
Secondary	Time taken to reach maximum plasma concentration (Tmax)	To characterize the PK profile of IDH305 with SOC medications (each Arm)	36 months
Secondary	Complete remission rate (CRR)	To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)	36 months
Secondary	Overall response rate (ORR)	To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)	36 months
Secondary	Event free survival (EFS)	To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)	36 months