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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00996892 |
Purpose
This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0941 administered in combination in patients with solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Cancers |
Drug: GDC-0941 Drug: GDC-0973/XL518 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors |
| Estimated Enrollment: | 62 |
| Study Start Date: | November 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: GDC-0941
Repeating oral dose
Drug: GDC-0973/XL518
Repeating oral 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: Meghan McKenzie | mckenzie.meghan@gene.com |
| United States, Massachusetts | |
| Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, Tennessee | |
| Investigational Site | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Study Director: | Iris Chan, M.D., Ph.D. | Genentech |
More Information
| Responsible Party: | Disclosures Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00996892 History of Changes |
| Other Study ID Numbers: | MEK4752g |
| Study First Received: | October 12, 2009 |
| Last Updated: | November 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
GDC0941 GDC0973 MEK MEK Inhibitor |
PI3K PI3K Inhibitor PI3 Kinase PI3 Kinase Inhibitor |