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GDC-0425

Phase 1

Solid Tumor | Small molecule | Oncology |Roche Holding AG|Last Updated: Apr 12, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0425 · 1 trial · 1 indication

Phase 1 1
NCT01359696A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or LymphomaSolid Tumor
COMPLETED40 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of all adverse events graded according to NCI CTCAE, v4.0
Up to 1 year
Incidence of dose limiting toxicities (DLTs)
Up to 35 days
Pharmacokinetic property of GDC-0425: determination of plasma drug concentration
Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: exposure
Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: half-life
Up to 12 months or early study discontinuation
Severity of all adverse events graded according to NCI CTCAE, v4.0
Up to 1 year

Secondary Endpoints

Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease
Up to 12 months or early study discontinuation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0425DRUGOral escalating dose
gemcitabineDRUGIntravenous repeating dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Signed Informed Consent Form * Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has...

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

Frequently asked questions about GDC-0425

What is GDC-0425 used for?

GDC-0425 is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development, and the completed trial evaluated its safety, tolerability, and pharmacokinetics when administered with and without gemcitabine in patients with refractory solid tumors or lymphoma.

Who makes GDC-0425?

GDC-0425 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of solid tumors.

What phase is GDC-0425 in?

GDC-0425 is in Phase 1 clinical development. The single trial for this drug, NCT01359696, has been completed. It is an investigational agent and has not been approved by regulatory authorities.

What clinical trials is GDC-0425 in?

GDC-0425 has one completed Phase 1 trial, NCT01359696, which enrolled 40 patients with refractory solid tumors or lymphoma. The study evaluated the safety, tolerability, and pharmacokinetics of GDC-0425 administered with and without gemcitabine in the United States and France.

Is GDC-0425 the same as any other drug?

GDC-0425 is the primary name for this investigational small molecule being developed by Roche Holding AG. No alternative names have been reported for this drug in the available clinical trial information.