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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381886
Recruitment Status : Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 6, 2015
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE March 6, 2015
Estimated Primary Completion Date June 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
Incident rate of dose limiting toxicities (DLTs) [ Time Frame: 9 months ]
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02381886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • Incidence of adverse events (AEs) [ Time Frame: 30 months ]
    To characterize the safety and tolerability of IDH305
  • Plasma PK parameters (AUC, Cmax, Tmax) [ Time Frame: 30 months ]
    To characterize the PK profile of IDH305
  • Changes of 2-hydroxyglutarate concentration in patient specimens [ Time Frame: 30 months ]
    To characterize the PD profile of IDH305
  • Overall response rate (ORR) [ Time Frame: 30 months ]
    To assess any preliminary anti-tumor activity of IDH305
  • Incidence of serious adverse events (SAE) [ Time Frame: 30 months ]
    To characterize the safety and tolerability of IDH305
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Official Title  ICMJE A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Brief Summary A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Malignancies That Harbor IDHR132 Mutations
Intervention  ICMJE Drug: IDH305
Study Arms  ICMJE Experimental: IDH305
Intervention: Drug: IDH305
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
166
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2015)
140
Estimated Study Completion Date  ICMJE June 12, 2020
Estimated Primary Completion Date June 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Germany,   Netherlands,   Singapore,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02381886
Other Study ID Numbers  ICMJE CIDH305X2101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP