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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00876122 |
This is an open-label, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941. This study will include patients with locally advanced or metastatic solid tumors or Non-Hodgkin's Lymphoma (NHL) for which standard therapy either does not exist or has proven ineffective or intolerable.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma 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 of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable |
Estimated Enrollment: | 48 |
Study Start Date: | March 2008 |
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:
Exclusion Criteria:
United Kingdom | |
Royal Marsden Hospital | Recruiting |
Sutton, United Kingdom, SM25PT | |
Contact: Krunal Shah 0208 722 4005 Krunal.Shah@icr.ac.uk |
Study Director: | Mika Derynck, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | GDC4254g |
Study First Received: | March 13, 2009 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00876122 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NHL Metastatic Solid Tumors PI3K Inhibitors PI3K |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |