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GDC-0917

Phase 1

Solid Cancers | 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

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0917 · 1 trial · 1 indication

Phase 1 1
NCT01226277A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or LymphomaSolid Cancers
COMPLETED42 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma
Solid Cancers
NCT0122627742
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Study Endpoints

Primary Endpoints

Changes in vital signs, ECGs, and clinical laboratory results
Throughout study or until early discontinuation
Incidence and nature of dose-limiting toxicities and adverse events of special interest
Throughout study or until early discontinuation
Incidence, nature, and severity of all adverse events and serious adverse events
Throughout study or until early discontinuation

Secondary Endpoints

Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state)
Throughout study or until early discontinuation
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0917DRUGOral repeating dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable * Life expectancy \>/= 12 weeks * Adequate hematologic and end organ function * For fem...

Countries:United States
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Frequently asked questions about GDC-0917

What is GDC-0917 used for?

GDC-0917 is an investigational small molecule being studied for the treatment of solid cancers. It is in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics in patients with refractory solid tumors or lymphoma.

What does GDC-0917 target?

The molecular target of GDC-0917 has not been disclosed in the available information. It is a small molecule in Phase 1 development for solid cancers, and its mechanism of action is not specified.

Who makes GDC-0917?

GDC-0917 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology drug.

What phase is GDC-0917 in?

GDC-0917 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for the treatment of solid cancers. One Phase 1 trial has been completed.

What clinical trials is GDC-0917 in?

GDC-0917 has one completed clinical trial, NCT01226277, which evaluated its safety, tolerability, and pharmacokinetics in patients with refractory solid tumors or lymphoma. The trial enrolled 42 participants in the United States.

Is GDC-0917 the same as any other drug?

GDC-0917 is not known to have alternative names in the available information. It is a distinct investigational compound being developed by Roche Holding AG for solid cancers.