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GDC-0349

Phase 1

Non-Hodgkin's Lymphoma, Solid Tumor | 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 Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

GDC-0349 · 1 trial · 1 indication

Phase 1 1
NCT01356173Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's LymphomaNon-Hodgkin's Lymphoma, Solid Tumor
COMPLETED10 Analytics
PHASE1COMPLETED
Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma, Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
Up to 30 days

Secondary Endpoints

Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349
Up to 2 years
Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349
Up to 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -

Interventions

NameTypeDescription
GDC-0349DRUGOral escalating dose
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Eligibility Criteria

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

Inclusion Criteria: * Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit * Evaluable or measurable di...

Countries:United StatesCanada
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Frequently asked questions about GDC-0349

What is GDC-0349 used for?

GDC-0349 is an investigational small molecule being studied for the treatment of Non-Hodgkin's Lymphoma and solid tumors. It is in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and tolerability in patients.

Who makes GDC-0349?

GDC-0349 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology drug, which is currently in Phase 1 development for Non-Hodgkin's Lymphoma and solid tumors.

What phase is GDC-0349 in?

GDC-0349 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for Non-Hodgkin's Lymphoma and solid tumors.

What clinical trials is GDC-0349 in?

GDC-0349 has one completed clinical trial, registered as NCT01356173. This Phase 1 study evaluated the safety and tolerability of GDC-0349 in patients with locally advanced or metastatic solid tumors or Non-Hodgkin's Lymphoma. The trial enrolled 10 participants and was conducted in the United States and Canada.

Is GDC-0349 the same as any other drug?

GDC-0349 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Roche Holding AG and is currently in Phase 1 clinical trials for Non-Hodgkin's Lymphoma and solid tumors.