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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04164901

Studienbeginn:
Januar 2020

Letztes Update:
09.02.2021

Wirkstoff:
AG-881, Matching Placebo

Indikation (Clinical Trials):
Glioma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Agios Pharmaceuticals, Inc.

Collaborator:
-

Kontakt

Studienlocations (3 von 60)

Klinikum Mannheim Universitätsklinikum
68135 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
85013 Phoenix
United StatesRekrutierend» Google-Maps
University of California San Diego
92093 La Jolla
United StatesRekrutierend» Google-Maps
UCLA Oncology Center
90095 Los Angeles
United StatesRekrutierend» Google-Maps
University of California Irvine - Hospital
92868 Orange
United StatesRekrutierend» Google-Maps
University of California San Francisco
94143 San Francisco
United StatesRekrutierend» Google-Maps
Stanford Cancer Center
94305 Stanford
United StatesRekrutierend» Google-Maps
University of Colorado Hospital - Anschutz Cancer Pavilion
80045 Aurora
United StatesRekrutierend» Google-Maps
HCA Research Institute Sarah Cannon
80113 Englewood
United StatesRekrutierend» Google-Maps
Yale University, Yale Cancer Center
06510 New Haven
United StatesRekrutierend» Google-Maps
Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
33136 Miami
United StatesRekrutierend» Google-Maps
Northwestern University
60611 Chicago
United StatesRekrutierend» Google-Maps
Indiana University Medical Center
46202 Indianapolis
United StatesRekrutierend» Google-Maps
University of Kansas Medical Center
66160 Kansas City
United StatesRekrutierend» Google-Maps
University of Kentucky
40536 Lexington
United StatesRekrutierend» Google-Maps
Maine Medical Partners Neurology
04074 Scarborough
United StatesRekrutierend» Google-Maps
John Hopkins Cancer Center
21231 Baltimore
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Dana-Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Metro Minnesota Community Oncology
55416 Minneapolis
United StatesRekrutierend» Google-Maps
Washington University School of Medicine - Siteman Cancer Center
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Duke University Medical Center
27710 Durham
United StatesRekrutierend» Google-Maps
Ohio State University Comprehensive Cancer Center
43210 Columbus
United StatesRekrutierend» Google-Maps
Oregon Health and Science University
97239 Portland
United StatesRekrutierend» Google-Maps
University of Pennsylvania
19104 Philadelphia
United StatesRekrutierend» Google-Maps
University of Pittsburgh Hillman Cancer Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Medical University of South Carolina
29425 Charleston
United StatesRekrutierend» Google-Maps
Vanderbilt Ingram Cancer Center
37232 Nashville
United StatesRekrutierend» Google-Maps
Baylor University Medical Center
75246 Dallas
United StatesRekrutierend» Google-Maps
University of Texas Southwestern Medical Center
75390 Dallas
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
The University of Utah, Huntsman Cancer Hospital
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
University of Virginia
22903 Charlottesville
United StatesRekrutierend» Google-Maps
Seattle Cancer Care Alliance
98109 Seattle
United StatesRekrutierend» Google-Maps
London Health Sciences Centre
N6A 5W9 London
CanadaRekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
Hospitalier Pitié Salpétrière
75013 Paris
FranceRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Azienda Ospedaliera Città della Salute e della Scienza di Torino
10126 Torino
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori Regina Elena
144 Roma
ItalyRekrutierend» Google-Maps
Universitair Medisch Centrum Utrecht
3584 CX Utrecht
NetherlandsRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebrón
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Universitätsspital Zürich
8006 Zürich
SwitzerlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled

study comparing the efficacy of AG-881 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 366 participants are planned to be randomized 1:1 to

receive orally administered AG-881 40 mg QD or placebo.

Ein-/Ausschlusskriterien

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 and not more

than 5 years before the date of randomization, and no other prior anticancer therapy,

including chemotherapy and radiotherapy.

- 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 blinded

independent review committee (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, etc.

- Have high-risk features as assessed 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).

Studien-Rationale

Primary outcome:

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



Secondary outcome:

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

2. Tumor Growth Rate as Assessed by Volume (Time Frame - Up to approximately 30 months)

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

4. Objective Response Rate (Time Frame - Up to approximately 30 months)

5. Time to Response (Time Frame - Up to approximately 30 months)

6. Duration of Response (Time Frame - Up to approximately 30 months)

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

8. 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.

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

10. Maximum Observed Serum Concentration (Cmax) of AG-881 (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)

11. Area Under Concentration Time Curve from Time 0 to Tau (AUC0-tau) of AG-881 (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)

12. Time to Reach Maximum Serum Concentration (Tmax) of AG-881 (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)

Studien-Arme

  • Experimental: AG-881
    AG-881 40 mg, continuous daily dosing.
  • Placebo Comparator: Matching Placebo
    Matching placebo 40 mg, continuous daily dosing. Participants who experience radiographic disease progression and who were receiving placebo will have the option to cross-over to AG-881, provided certain criteria are met.

Geprüfte Regime

  • AG-881:
    AG-881 oral film-coated tablets
  • Matching Placebo:
    Matching Placebo oral tablets

Quelle: ClinicalTrials.gov


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