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GDC-0919

Phase 1

Solid Tumor | Small molecule | Oncology |Roche Holding AG|Last Updated: Feb 6, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0919 · 1 trial · 1 indication

Phase 1 1
NCT02048709Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid TumorsSolid Tumor
COMPLETED22 Analytics
PHASE1COMPLETED
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of patients with dose-limiting toxicities
28 days
Number of dose-limiting toxicities
28 days
Percentage of patients with adverse events
approximately 15 months

Secondary Endpoints

Pharmacokinetics: Serum concentrations (Cmax/Steady State)
21 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GDC-0919 Dose EscalationEXPERIMENTALGDC-0919 to be given on an outpatient basis as a single agent. Starting dose of GDC-0919 will be 50 mg by mouth every 12 hour. Patients will receive the study drug daily for 21 days followed by 7 days off for a cycle length of 28 days; or on 28 consecutive days of a 28-day cycle

Interventions

NameTypeDescription
GDC-0919DRUGSupplied in 50 mg and 200 mg capsules. To be taken every 12 hours with water by mouth on an empty stomach (no food or drink other than water for 2 hours prior to dose). Taken twice daily for 21 days each cycle, followed by 7 days off; or taken twice daily on 28 consecutive days of a 28-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists * Age \> or = 18 * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * Life expectancy \> or = 12 weeks *...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about GDC-0919

What is GDC-0919 used for?

GDC-0919 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development for oncology indications. The drug is not yet approved and remains under investigation in clinical trials.

What does GDC-0919 target?

GDC-0919 is an indoleamine 2,3-dioxygenase (IDO) inhibitor. It is being studied in advanced solid tumors as part of a Phase 1 clinical trial. The drug targets the IDO pathway, which is involved in immune regulation in the tumor microenvironment.

Who makes GDC-0919?

GDC-0919 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY. The drug is currently in Phase 1 clinical development for solid tumors.

What phase is GDC-0919 in?

GDC-0919 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of solid tumors in an early-stage clinical trial.

What clinical trials is GDC-0919 in?

GDC-0919 has been studied in one clinical trial, identified as NCT02048709, titled 'Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors.' This Phase 1 trial was completed and enrolled 22 participants in the United States.

Is GDC-0919 the same as an IDO inhibitor?

Yes, GDC-0919 is an indoleamine 2,3-dioxygenase (IDO) inhibitor. It is being investigated for its potential role in treating solid tumors by targeting the IDO pathway. The drug is currently in Phase 1 clinical development.