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GDC-0068

Phase 1

Solid Cancers | Small molecule | Oncology |Roche Holding AG|Last Updated: Jul 4, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0068 · 1 trial · 1 indication

Phase 1 1
NCT01090960A Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid TumorsSolid Cancers
COMPLETED52 Analytics
PHASE1COMPLETED
A Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors
Solid CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068
Through study completion or early study discontinuation
Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068
Through study completion or early study discontinuation
Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068
Through study completion or early study discontinuation
PK parameters after single and multiple doses of GDC-0068
Through study completion or early study discontinuation

Secondary Endpoints

Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST
Through study completion or early study discontinuation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0068DRUGOral repeating dose
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Eligibility Criteria

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

Inclusion Criteria: * Histologically documented, incurable, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable. * Evaluable or measurable disease * Life expectancy \>= 12 weeks * Adequate hematologic and organ functi...

Countries:Spain
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Frequently asked questions about GDC-0068

What is GDC-0068 used for?

GDC-0068 is an investigational small molecule being studied for the treatment of solid cancers. It is being developed by Roche Holding AG (ticker: RHHBY) and has completed a Phase 1 clinical trial in patients with refractory solid tumors.

What does GDC-0068 target?

The specific molecular target of GDC-0068 has not been disclosed in the available information. It is a small molecule in development for oncology indications, but its mechanism of action is not specified.

Who makes GDC-0068?

GDC-0068 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.

What phase is GDC-0068 in?

GDC-0068 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still in the early stages of clinical testing.

What clinical trials is GDC-0068 in?

GDC-0068 has one completed clinical trial, identified as NCT01090960. This Phase 1 study evaluated the safety and tolerability of GDC-0068 in 52 patients with refractory solid tumors. The trial was conducted in Spain and enrolled adults aged 18 years and older.