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GDC-0623

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

UNCONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0623 · 1 trial · 1 indication

Phase 1 1
NCT01106599A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid TumorsSolid Cancers
COMPLETED61 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors
Solid CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and nature of dose-limiting toxicities (DLTs)
Through study completion or early discontinuation
Incidence, nature, and severity of adverse events and serious adverse events, graded according to NCI CTCAE, v4.0
Through study completion or early discontinuation
Pharmacokinetic parameters of GDC-0623 (total exposure, maximum and minimum plasma concentrations, time to maximum plasma concentration, elimination half-life)
Through study completion or early discontinuation

Secondary Endpoints

Objective response for patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Through study completion or early discontinuation
Duration of objective response for patients with measurable disease according to RECIST
Through study completion or early discontinuation
Progression-free survival (PFS) for patients with measurable disease according to RECIST
Through study completion or early discontinuation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0623DRUGRepeating oral dose
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Eligibility Criteria

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

Inclusion Criteria: * 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 disease measurable per RECIST * Life expectancy \>= 12 weeks * Adequate hema...

Countries:United States
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Frequently asked questions about GDC-0623

What is GDC-0623 used for?

GDC-0623 is an investigational small molecule being studied for the treatment of solid cancers. It is intended for patients with locally advanced or metastatic solid tumors. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does GDC-0623 target?

The molecular target of GDC-0623 has not been disclosed in available information. The drug is a small molecule being evaluated for its safety, tolerability, and pharmacokinetics in patients with solid tumors. Its mechanism of action is not publicly detailed.

Who makes GDC-0623?

GDC-0623 is being developed by Roche Holding AG, a multinational healthcare company. Roche is listed on the OTC market under the ticker symbol RHHBY. The drug is currently in Phase 1 clinical development.

What phase is GDC-0623 in?

GDC-0623 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for safety, tolerability, and pharmacokinetics in patients with solid tumors.

What clinical trials is GDC-0623 in?

GDC-0623 has one completed clinical trial, NCT01106599, which evaluated the safety, tolerability, and pharmacokinetics of the drug in patients with locally advanced or metastatic solid tumors. The trial was conducted in the United States and enrolled 61 participants.