search
Back to results

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Primary Purpose

Grade 2 Glioma, Residual Glioma, Recurrent Glioma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vorasidenib
Matching Placebo
Sponsored by
Institut de Recherches Internationales Servier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Grade 2 Glioma focused on measuring AG-881

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Be at least 12 years of age and weigh at least 40 kg.
  • Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
  • Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
  • Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory.
  • Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC.
  • Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.

Key Exclusion Criteria:

  • Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
  • Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope
  • University of California San Diego
  • UCLA Oncology Center
  • University of California Irvine - Hospital
  • University of California San Francisco
  • Stanford Cancer Center
  • University of Colorado Hospital - Anschutz Cancer Pavilion
  • Yale University, Yale Cancer Center
  • Mayo Clinic Jacksonville
  • Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
  • Northwestern University
  • University of Chicago
  • Indiana University Medical Center
  • University of Kansas Medical Center
  • University of Kentucky
  • Maine Medical Partners Neurology
  • John Hopkins Cancer Center
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Henry Ford Hospital
  • Metro Minnesota Community Oncology
  • Mayo Comprehensive Cancer
  • Washington University School of Medicine
  • Columbia University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center
  • Ohio State University Comprehensive Cancer Center
  • Oregon Health and Science University
  • University of Pennsylvania
  • University of Pittsburgh Hillman Cancer Center
  • Medical University of South Carolina
  • Tennessee Oncology
  • Baylor University Medical Center
  • University of Texas Southwestern Medical Center
  • MD Anderson Cancer Center
  • The University of Utah, Huntsman Cancer Hospital
  • Seattle Cancer Care Alliance
  • BC Cancer Agency
  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Hospital
  • McGill University Health Center
  • Centre Hospitalier Universitaire de Lille
  • Hôpital Pierre Wertheimer
  • Hopitaux de La Timone
  • Hospitalier Pitié Salpétrière
  • Universitätsklinikum Essen
  • Universitätsklinikum Hamburg Eppendorf
  • Universitätsklinikum Heidelberg
  • Klinikum Mannheim Universitätsklinikum
  • Hadassah Medical Center
  • Rabin Medical Center
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Ospedale Bellaria
  • Istituto Oncologico Veneto - I.R.C.C.S.
  • Istituto Nazionale Tumori Regina Elena
  • Istituto Clinico Humanitas
  • Nagoya University Hospital
  • Fujita Health University Hospital
  • Hiroshima University Hospital
  • The University of Tokyo Hospital
  • National Cancer Center Hospital
  • Kumamoto University Hospital
  • University Hospital, Kyoto Prefectural University of Medicine
  • Kyoto University Hospital
  • Okayama University Hospital
  • Haaglanden MC, Antoniushove
  • Leiden University Medical Center
  • Universitair Medisch Centrum Utrecht
  • Hospital Universitario Vall d'Hebrón
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hôpitaux Universitaire de Genève
  • Centre Hospitalier Universitaire Vaudois
  • Universitätsspital Zürich
  • Freeman Hospital
  • The Royal Marsden NHS Foundation Trust
  • Western General Hospital Edinburgh - PPDS
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vorasidenib

Matching Placebo

Arm Description

Vorasidenib 40 mg, continuous daily dosing.

Matching placebo 40 mg, continuous daily dosing. Participants who experience centrally-confirmed radiographic disease progression and who were receiving placebo will have the option to cross-over to vorasidenib, provided certain criteria are met.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

Secondary Outcome Measures

Time to Next Intervention
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tumor Growth Rate as Assessed by Volume per the Blinded Independent Review Committee (BIRC)
Objective Response as Assessed per the BIRC and Investigator
Complete Response (CR) + Partial Response (PR) with Response Assessed per the BIRC and Investigator
Time to Response with Response Assessed per the BIRC and Investigator
Time to CR + PR with Response Assessed per the BIRC and Investigator
Duration of Response with Response Assessed per the BIRC and Investigator
Duration of CR + PR with Response Assessed per the BIRC and Investigator
Overall Survival
Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br)
The FACT-Br is a participant-reported measure designed to assess the quality of life for participants with brain tumors. The FACT-Br is a measure comprising the following subscales: Physical Well-Being, Functional Well-Being, Emotional Well-Being, and Social Well-Being subscales from the FACT-G, with the addition of a brain tumor- specific subscale.
Progression-Free Survival (PFS) as Assessed by the Investigator
Pharmacokinetics: Plasma Concentrations of Vorasidenib Collected at Specified Time Points
Pharmacokinetics: Plasma Concentrations of Metabolite, AGI-69460, Collected at Specified Time Points

Full Information

First Posted
November 11, 2019
Last Updated
July 7, 2023
Sponsor
Institut de Recherches Internationales Servier
search

1. Study Identification

Unique Protocol Identification Number
NCT04164901
Brief Title
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Internationales Servier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade 2 Glioma, Residual Glioma, Recurrent Glioma
Keywords
AG-881

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized in a 1:1 allocation (vorasidenib vs Placebo)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vorasidenib
Arm Type
Experimental
Arm Description
Vorasidenib 40 mg, continuous daily dosing.
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo 40 mg, continuous daily dosing. Participants who experience centrally-confirmed radiographic disease progression and who were receiving placebo will have the option to cross-over to vorasidenib, provided certain criteria are met.
Intervention Type
Drug
Intervention Name(s)
Vorasidenib
Other Intervention Name(s)
AG-881
Intervention Description
Vorasidenib oral film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Matching Placebo oral tablets
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Time Frame
Up to approximately 30 months
Secondary Outcome Measure Information:
Title
Time to Next Intervention
Time Frame
Up to approximately 5 years
Title
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to approximately 30 months
Title
Tumor Growth Rate as Assessed by Volume per the Blinded Independent Review Committee (BIRC)
Time Frame
Up to approximately 30 months
Title
Objective Response as Assessed per the BIRC and Investigator
Time Frame
Up to approximately 30 months
Title
Complete Response (CR) + Partial Response (PR) with Response Assessed per the BIRC and Investigator
Time Frame
Up to approximately 30 months
Title
Time to Response with Response Assessed per the BIRC and Investigator
Time Frame
Up to approximately 30 months
Title
Time to CR + PR with Response Assessed per the BIRC and Investigator
Time Frame
Up to approximately 30 months
Title
Duration of Response with Response Assessed per the BIRC and Investigator
Time Frame
Up to approximately 30 months
Title
Duration of CR + PR with Response Assessed per the BIRC and Investigator
Time Frame
Up to approximately 30 months
Title
Overall Survival
Time Frame
Up to approximately 5 years
Title
Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br)
Description
The FACT-Br is a participant-reported measure designed to assess the quality of life for participants with brain tumors. The FACT-Br is a measure comprising the following subscales: Physical Well-Being, Functional Well-Being, Emotional Well-Being, and Social Well-Being subscales from the FACT-G, with the addition of a brain tumor- specific subscale.
Time Frame
Up to approximately 30 months
Title
Progression-Free Survival (PFS) as Assessed by the Investigator
Time Frame
Up to approximately 30 months
Title
Pharmacokinetics: Plasma Concentrations of Vorasidenib Collected at Specified Time Points
Time Frame
Days 1 and 15 of Cycle 1(predose and multiple timepoints up to 4 hours postdose), Day 1 of Cycle 2(predose and multiple time points up to 4 hours postdose), Predose on Day 1 of every cycle thereafter(each cycle is 28 days), and within 7 days of last dose
Title
Pharmacokinetics: Plasma Concentrations of Metabolite, AGI-69460, Collected at Specified Time Points
Time Frame
Days 1 and 15 of Cycle 1(predose and multiple timepoints up to 4 hours postdose), Day 1 of Cycle 2(predose and multiple time points up to 4 hours postdose), Predose on Day 1 of every cycle thereafter(each cycle is 28 days), and within 7 days of last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Be at least 12 years of age and weigh at least 40 kg. Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory. Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC. Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%. Key Exclusion Criteria: Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc. Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCLA Oncology Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Irvine - Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University, Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Maine Medical Partners Neurology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
John Hopkins Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Metro Minnesota Community Oncology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Mayo Comprehensive Cancer
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Utah, Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
BC Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Hopitaux de La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hospitalier Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Mannheim Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Istituto Oncologico Veneto - I.R.C.C.S.
City
Padua
ZIP/Postal Code
35128
Country
Italy
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
144
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Hiroshima University Hospital
City
Minami-Ku
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Haaglanden MC, Antoniushove
City
Leidschendam
State/Province
Zuid-Holland
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hôpitaux Universitaire de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8006
Country
Switzerland
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Western General Hospital Edinburgh - PPDS
City
Edinburgh
ZIP/Postal Code
EH4 2XY
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD Sharing Time Frame
After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD Sharing Access Criteria
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
IPD Sharing URL
https://clinicaltrials.servier.com/
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://clinicaltrials.servier.com/
Available IPD/Information Type
Study-level clinical trial data
Available IPD/Information URL
https://clinicaltrials.servier.com/

Learn more about this trial

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

We'll reach out to this number within 24 hrs