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History of Changes for Study: NCT02381886
A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
Latest version (submitted December 9, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 2, 2015 None (earliest Version on record)
2 March 5, 2015 Contacts/Locations, Study Description, Study Status and Study Identification
3 April 6, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 April 17, 2015 Contacts/Locations and Study Status
5 April 27, 2015 Contacts/Locations and Study Status
6 June 1, 2015 Study Status and Contacts/Locations
7 June 11, 2015 Contacts/Locations and Study Status
8 June 18, 2015 Contacts/Locations and Study Status
9 June 23, 2015 Contacts/Locations and Study Status
10 July 31, 2015 Contacts/Locations and Study Status
11 August 25, 2015 Contacts/Locations and Study Status
12 November 5, 2015 Study Status, Study Design, Contacts/Locations and Conditions
13 January 12, 2016 Contacts/Locations, Study Status and Conditions
14 May 26, 2016 Contacts/Locations, Study Status, Eligibility and Conditions
15 June 29, 2016 Contacts/Locations and Study Status
16 August 1, 2016 Contacts/Locations and Study Status
17 September 4, 2016 Study Status
18 November 29, 2016 Recruitment Status, Study Status and Contacts/Locations
19 July 12, 2017 Study Status
20 August 1, 2017 Study Status, Oversight, IPDSharing and Contacts/Locations
21 April 30, 2018 Recruitment Status, Study Status, Study Design and Contacts/Locations
22 May 30, 2018 Study Status
23 August 24, 2018 Study Status
24 September 27, 2018 Study Status
25 May 22, 2019 Study Status
26 July 16, 2019 Study Status
27 June 19, 2020 Study Status, Contacts/Locations and Study Design
28 March 10, 2021 Study Status
29 April 27, 2021 Study Status
30 July 23, 2021 Study Status, Contacts/Locations and Outcome Measures
31 December 9, 2021 Study Status
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Study NCT02381886
Submitted Date:  March 2, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: CIDH305X2101
Brief Title: A Phase I 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Not yet recruiting
Study Start: February 2015
Primary Completion: November 2017 [Anticipated]
Study Completion: November 2017 [Anticipated]
First Submitted: March 2, 2015
First Submitted that
Met QC Criteria:
March 2, 2015
First Posted: March 6, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 2, 2015
Last Update Posted: March 6, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Malignancies That Harbor IDHR132 Mutations
Keywords: Advanced malignancies,
IDHR132 mutations,
IDH305
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: IDH305 Drug: IDH305
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incident rate of dose limiting toxicities (DLTs)
[ Time Frame: 9 months ]

To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
Secondary Outcome Measures:
1. Incidence of adverse events (AEs)
[ Time Frame: 30 months ]

To characterize the safety and tolerability of IDH305
2. Plasma PK parameters (AUC, Cmax, Tmax)
[ Time Frame: 30 months ]

To characterize the PK profile of IDH305
3. Changes of 2-hydroxyglutarate concentration in patient specimens
[ Time Frame: 30 months ]

To characterize the PD profile of IDH305
4. Overall response rate (ORR)
[ Time Frame: 30 months ]

To assess any preliminary anti-tumor activity of IDH305
5. Incidence of serious adverse events (SAE)
[ Time Frame: 30 months ]

To characterize the safety and tolerability of IDH305
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Documented IDH1R132-mutant tumors
  • Disease that has progressed since last prior therapy and for which there is no curative therapy
  • 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

Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: 1-888-669-6682
Central Contact Backup: Novartis Pharmaceuticals
Study Officials: Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Locations: United States, Massachusetts
Dana Farber Cancer Institute SC (1)
Boston, Massachusetts, United States, 02115
Contact:Contact: Karly Griffin 617-632-6749 karly_griffin@dfci.harvard.edu
Contact:Principal Investigator: Patrick Y Wen
United States, New York
Columbia University Medical Center- New York Presbyterian Onc Dept.
New York, New York, United States, 10032
Contact:Contact: Barbara Santiago 212-305-3846 bs2845@columbia.edu
Contact:Principal Investigator: Gary K. Schwartz
United States, Texas
University of Texas/MD Anderson Cancer Center Dept. of Onc.
Houston, Texas, United States, 77030-4009
Contact:Contact: Vanda Stepanek 713-563-1193 vstepane@mdanderson.org
Contact:Principal Investigator: Filip Janku
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Germany
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Jena, Germany, 07740
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain, Catalunya
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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