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



Januar 2020

Letztes Update:

Matching Placebo, Vorasidenib

Indikation (Clinical Trials):



Phase 3

Agios Pharmaceuticals, Inc.



(3 von 73)

Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
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Universitätsklinikum Hamburg Eppendorf
20246 Hamburg
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Universitätsklinikum Heidelberg
69120 Heidelberg
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Klinikum Mannheim Universitätsklinikum
68135 Mannheim
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University of Alabama at Birmingham
35294 Birmingham
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St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
85013 Phoenix
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University of California San Diego
92093 La Jolla
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UCLA Oncology Center
90095 Los Angeles
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University of California Irvine - Hospital
92868 Orange
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University of California San Francisco
94143 San Francisco
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Stanford Cancer Center
94305 Stanford
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University of Colorado Hospital - Anschutz Cancer Pavilion
80045 Aurora
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HCA Research Institute Sarah Cannon
80113 Englewood
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Yale University, Yale Cancer Center
06510 New Haven
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Mayo Clinic Jacksonville
32224 Jacksonville
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Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
33136 Miami
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Northwestern University
60611 Chicago
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Indiana University Medical Center
46202 Indianapolis
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University of Kansas Medical Center
66160 Kansas City
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University of Kentucky
40536 Lexington
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Maine Medical Partners Neurology
04074 Scarborough
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John Hopkins Cancer Center
21231 Baltimore
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Massachusetts General Hospital
02114 Boston
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Dana-Farber Cancer Institute
02215 Boston
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University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
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Metro Minnesota Community Oncology
55416 Minneapolis
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Mayo Comprehensive Cancer
55905 Rochester
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Washington University School of Medicine - Siteman Cancer Center
63110 Saint Louis
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Icahn School of Medicine at Mount Sinai
10029 New York
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Columbia University Medical Center
10032 New York
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Memorial Sloan Kettering Cancer Center
10065 New York
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Duke University Medical Center
27710 Durham
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Ohio State University Comprehensive Cancer Center
43210 Columbus
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Oregon Health and Science University
97239 Portland
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University of Pennsylvania
19104 Philadelphia
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University of Pittsburgh Hillman Cancer Center
15232 Pittsburgh
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Medical University of South Carolina
29425 Charleston
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Vanderbilt Ingram Cancer Center
37232 Nashville
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Baylor University Medical Center
75246 Dallas
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University of Texas Southwestern Medical Center
75390 Dallas
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MD Anderson Cancer Center
77030 Houston
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The University of Utah, Huntsman Cancer Hospital
84112 Salt Lake City
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University of Virginia
22903 Charlottesville
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Seattle Cancer Care Alliance
98109 Seattle
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London Health Sciences Centre
N6A 5W9 London
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Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
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75013 Paris
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Tel Aviv Sourasky Medical Center
6423906 Tel Aviv
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10126 Torino
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Istituto Nazionale Tumori Regina Elena
144 Roma
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Haaglanden MC, Antoniushove
2262 BA Leidschendam
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2333 ZA Leiden
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3584 CX Utrecht
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08035 Barcelona
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28034 Madrid
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28041 Madrid
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1211 Geneva
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1011 Lausanne
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8006 Zürich
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M20 4BX Manchester
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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.


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


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).


Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to approximately 30 months)

Secondary outcome:

1. Time to Next Intervention (Time Frame - Up to approximately 5 years)

2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Up to approximately 30 months)

3. Tumor Growth Rate as Assessed by Volume per the Blinded Independent Review Committee (BIRC) (Time Frame - Up to approximately 30 months)

4. Objective Response as Assessed per the BIRC and Investigator (Time Frame - Up to approximately 30 months)

5. Complete Response (CR) + Partial Response (PR) with Response Assessed per the BIRC and Investigator (Time Frame - Up to approximately 30 months)

6. Time to Response with Response Assessed per the BIRC and Investigator (Time Frame - Up to approximately 30 months)

7. Time to CR + PR with Response Assessed per the BIRC and Investigator (Time Frame - Up to approximately 30 months)

8. Duration of Response with Response Assessed per the BIRC and Investigator (Time Frame - Up to approximately 30 months)

9. Duration of CR + PR with Response Assessed per the BIRC and Investigator (Time Frame - Up to approximately 30 months)

10. Overall Survival (Time Frame - Up to approximately 5 years)

11. Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br) (Time Frame - Up to approximately 30 months):
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.

12. Progression-Free Survival (PFS) as Assessed by the Investigator (Time Frame - Up to approximately 30 months)

13. 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)

14. 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)


  • Experimental: Vorasidenib
    Vorasidenib 40 mg, continuous daily dosing.
  • Placebo Comparator: Matching Placebo
    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.

Geprüfte Regime

  • Vorasidenib (AG-881):
    Vorasidenib oral film-coated tablets
  • Matching Placebo:
    Matching Placebo oral tablets


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