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GDC-0994

Phase 1

Solid Tumor | Small molecule | Oncology |Roche Holding AG|Last Updated: Apr 6, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0994 · 1 trial · 1 indication

Phase 1 1
NCT01875705A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid TumorsSolid Tumor
COMPLETED40 Analytics
PHASE1COMPLETED
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
Approximately 2 years
Maximum tolerated dose
Approximately 2 years
Dose-limiting toxicities
Approximately 2 years
Pharmacokinetics: Area under the concentration-time curve
Approximately 2 years
Pharmacokinetics: Maximum plasma concentrations
Approximately 2 years
Pharmacokinetics: Minimum plasma concentrations
Approximately 2 years
Pharmacokinetics: Time to maximum plasma concentration
Approximately 2 years
Pharmacokinetics: Apparent terminal elimination half-life
Approximately 2 years

Secondary Endpoints

To assess the PD effects of GDC-0994, as measured by changes in molecular biomarkers in pre- and post-treatment tumor tissues\n
Approximately 2 years
Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Approximately 2 years
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Approximately 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Stage I-Dose EscalationEXPERIMENTAL -
Stage II-Cohort-ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0994DRUGEscalating doses of GDC-0994 until maximum tolerated dose is reached
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable * Evaluable disease or dis...

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

Frequently asked questions about GDC-0994

What is GDC-0994 used for in solid tumors?

GDC-0994 is an investigational small molecule being studied for the treatment of locally advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and tolerability in patients with solid tumors.

Who makes GDC-0994?

GDC-0994 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's potential in oncology.

What phase is GDC-0994 in?

GDC-0994 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials according to available data.

What clinical trials is GDC-0994 in?

GDC-0994 has been studied in one clinical trial, identified as NCT01875705. This was a Phase 1 dose-escalation study in patients with locally advanced or metastatic solid tumors. The trial enrolled 40 participants and was conducted in the United States and France. It has been completed.

Is GDC-0994 FDA approved?

GDC-0994 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug remains in clinical development and has not been authorized for commercial use by the FDA or any other regulatory agency.