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Report for Clinical Trial NCT03970447

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

NCT03970447 Glioblastoma
MeSH:Glioblastoma
HPO:Glioblastoma multiforme

4 Interventions

Name: Temozolomide

Description: Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg
Type: Drug
Group Labels: 1

Control Arm

Name: Lomustine

Description: Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg
Type: Drug
Group Labels: 1

Control Arm

Name: Regorafenib

Description: Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Type: Drug
Group Labels: 1

Regorafenib Treatment Arm

Name: Radiation

Description: 60 Gy
Type: Radiation
Group Labels: 2

Control Arm Regorafenib Treatment Arm


Primary Outcomes

Description: Overall survival is defined from the time of randomization to death from any cause. Patients still alive at the time of an analysis will be considered censored at their date of last contact.

Measure: Overall Survival (OS)

Time: From date of randomization until the date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Secondary Outcomes

Description: Progression-free survival is defined as the time from randomization to clinically determined progression or death from any cause. All participants will be included in the analysis of PFS.

Measure: Progression-free survival (PFS)

Time: From date of randomization to date of clinically determined progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Description: Tumor response is categorized by Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Response captured from initiation of study treatment until disease progression.

Measure: Tumor Response

Time: From initiation of study treatment to date of disease progression, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Description: Duration of response (CR+PR) is defined as time from date of response to date of clinically determined disease progression or death from any cause.

Measure: Duration of Response (CR + PR)

Time: From date of response to date of clinically determined disease progression or date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Purpose: Treatment

Allocation: Randomized

Sequential Assignment


There is one SNP

SNPs


1 R132H

- Histologically confirmed GBM/gliosarcoma (WHO criteria; non-IDH R132H mutant) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT). --- R132H ---



HPO Nodes


HPO: