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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00876109 |
This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered once a day (QD) and twice a day (BID).
Condition | Intervention | Phase |
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Solid Cancers |
Drug: GDC-0941 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label, Phase I, Dose-Escalation Study Evaluating Two Dosing Schedules of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable |
Estimated Enrollment: | 48 |
Study Start Date: | October 2007 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: GDC-0941
Escalating oral dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient must meet the following criteria to be eligible for study entry:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
United States, Arizona | |
TGen Clinical Research Srvs | Recruiting |
Scottsdale, Arizona, United States, 85258 | |
Contact: Lynne Hull 480-323-1071 LHull@SHC.org | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Sarah Solomon 617-582-7503 Sarah_Solomon@dfci.harvard.edu | |
United States, Michigan | |
Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Jie Zhang 313-576-9365 zhangj@karmanos.org |
Study Director: | Mika Derynck, M.D | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | GDC4255g |
Study First Received: | March 13, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00876109 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Solid Tumors PI3K PI3K Inhibitors |