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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00854152 |
Purpose
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Solid Cancers |
Drug: GDC-0980 |
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 the Safety and Tolerability of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors or Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 75 |
| Study Start Date: | March 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: GDC-0980
Escalating repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mick O'Quigley | oquigley.michael@gene.com |
| United States, Massachusetts | |
| Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Tennessee | |
| Investigational Site | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| United Kingdom | |
| Investigational Site | Recruiting |
| Sutton, United Kingdom, SM25PT | |
| Study Director: | Mika Derynck, M.D. | Genentech |
More Information
| Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
| Study ID Numbers: | PIM4604g |
| Study First Received: | February 27, 2009 |
| Last Updated: | September 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00854152 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
NHL Tumors Carcinogenic Tumors |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |