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

April 8, 2019 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Medically fit for induction
IDH305 + Standard of care for patients that are medically fit for induction.
Drug: IDH305
Experimental: Arm 2 Medically unfit for induction
IDH305 + Standard of care for patients that are medically unfit for induction.
Drug: IDH305

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting toxicities
Time Frame: 10 months
(escalation only)
10 months
Number of patients with adverse events (AEs)
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under Curve (AUC)
Time Frame: 36 months
To characterize the PK profile of IDH305 with SOC medications (each Arm)
36 months
Maximum Plasma Concentration (Cmax)
Time Frame: 36 months
To characterize the PK profile of IDH305 with SOC medications (each Arm)
36 months
Time taken to reach maximum plasma concentration (Tmax)
Time Frame: 36 months
To characterize the PK profile of IDH305 with SOC medications (each Arm)
36 months
Complete remission rate (CRR)
Time Frame: 36 months
To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
36 months
Overall response rate (ORR)
Time Frame: 36 months
To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
36 months
Event free survival (EFS)
Time Frame: 36 months
To characterize preliminary anti-tumor activity for each arm of the study. (Arm 1 and Arm 2)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2016

Primary Completion (Anticipated)

November 29, 2016

Study Completion (Anticipated)

November 29, 2016

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDH305X2102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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