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GDC-0084

Phase 1

Glioblastoma, Glioma | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0084 · 1 trial · 1 indication

Phase 1 1
NCT01547546A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade GliomaGlioblastoma, Glioma
COMPLETED29 Analytics
PHASE1COMPLETED
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
Glioblastoma, GliomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
approximately 2 years
Maximum tolerated dose (MTD)
approximately 1 year

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve
Pre- and post-dose Days 1, 8, 15, 22 and 29 Cycle 1, Day 1 every following Cycle until 30 days after the last dose of study drug
Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)
approximately 2 years
Duration of response
approximately 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0084DRUGMultiple doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry * Karnofsky Performance Status of \>/= 70 at screening * Confirmed measurable disease per RANO * Adequate hematologic and organ function Pa...

Countries:United StatesSpain
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Frequently asked questions about GDC-0084

What is GDC-0084 used for?

GDC-0084 is an investigational small molecule being studied for the treatment of glioblastoma and glioma, which are types of high-grade brain tumors. It is intended for patients with progressive or recurrent high-grade glioma. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes GDC-0084?

GDC-0084 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with brain tumors.

What phase is GDC-0084 in?

GDC-0084 is in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in patients with progressive or recurrent high-grade glioma. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is GDC-0084 in?

GDC-0084 has been studied in one completed clinical trial with the identifier NCT01547546. This Phase 1 study enrolled 29 participants with glioblastoma or glioma and was conducted in the United States and Spain. The trial was uncontrolled, meaning there was no comparison group, and it included patients aged 18 years and older.

Is GDC-0084 the same as any other drug?

GDC-0084 is the primary name for this investigational compound. No alternative names have been reported for this drug in the available clinical trial information. It is a distinct small molecule being developed by Roche for the treatment of high-grade gliomas.