A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential

2014-08-27 03:18:47 | BioPortfolio


This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part A and dosing the first subject in Part B. In each part, 6 healthy female subjects of non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.

Study Design

Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment




GDC-0449, GDC-0449


Investigational Site
9471 GP





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:47-0400

Clinical Trials [23 Associated Clinical Trials listed on BioPortfolio]

A Study of GDC-0449 (Hedgehog Pathway Inhibitor) in Patients Treated With GDC-0449 in a Previous Genentech-Sponsored Phase I or II Cancer Study

This is a multicenter, open-label extension study. Patients receiving GDC-0449 in a Genentech-sponsored study who have completed the parent study or who continue to receive GDC-0449 at th...

GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

RATIONALE: GDC-0449 may be effective in treating patients with glioblastoma multiforme. PURPOSE: This randomized phase II trial is studying how well GDC-0449 works in treating patients wi...

A Study of GDC-0449 (Hedgehog Pathway Inhibitor) As Maintenance Therapy in Patients With Ovarian Cancer in a Second or Third Complete Remission

The proposed study is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of GDC-0449 in patients with ovarian cancer in a second or third complete remissi...

GDC-0449 and RO4929097 in Treating Women With Advanced Breast Cancer

RATIONALE: GDC-0449 and RO4929097 may slow the growth of tumor cells and may be an effective treatment for advanced breast cancer. PURPOSE: This phase I trial is studying the side effects...

GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment

RATIONALE: GDC-0449 may be effective in treating young patients with medulloblastoma. PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating young ...

PubMed Articles [4418 Associated PubMed Articles listed on BioPortfolio]

Novel-smoothened inhibitors for therapeutic targeting of naïve and drug-resistant hedgehog pathway-driven cancers.

The G protein-coupled receptor (GPCR) smoothened (SMO) is a key signaling component of the sonic hedgehog (Hh) pathway and a clinically validated target for cancer treatment. The FDA-approved SMO inhi...

PEG-b-poly (carbonate)-derived nanocarrier platform with pH-responsive properties for pancreatic cancer combination therapy.

A pH-responsive nanoparticle platform, based on PEG-b-poly (carbonate) block copolymers have been proposed that can respond to low pH as found in many cancer micro- and intracellular environment, incl...

Acute pain and post-herpetic neuralgia related to Varicella Zoster Virus reactivation: comparison between typical herpes zoster and zoster sine herpete.

Herpes Zoster (HZ) is typically characterized by pain involving the area of vesicular eruption. Several patients, however, complain of unilateral radicular pain without rash (zoster sine herpete (ZSH)...

Peace, Love, Field Day: An Innovative Approach to Cultivating Healthy Academic Communities.

The American Nurses Association declared 2017 the Year of the Healthy Nurse. In an effort to promote a healthy academic environment, faculty and staff in institutions of higher learning should serve a...

Analysis of Cranial Morphology of Healthy Infants Using Homologous Modeling.

Data on cranial morphology of healthy individuals can be used as the guide in the treatment of cranial deformity. There are many reports analyzing the cranial morphology of healthy children in the pas...

Medical and Biotech [MESH] Definitions

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.

Process of evaluating the health of a patient and determining if they are healthy enough for surgery.

Dietary patterns which have been found to be important in reducing disease risk.

More From BioPortfolio on "A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial