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| Sponsor: | Genentech |
|---|---|
| Information provided by (Responsible Party): | 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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of GDC-0980 Administered Once Daily in Patients With Refractory Solid Tumors and Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 105 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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: Please reference Study ID Number: PIM4604g | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
| United States, Illinois | |
| Not yet recruiting | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Not yet recruiting | |
| New York, New York, United States, 10065 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 37203 | |
| United Kingdom | |
| Recruiting | |
| Sutton, United Kingdom, SM2 5PT | |
| Study Director: | Mika Derynck, M.D. | Genentech |
More Information
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00854152 History of Changes |
| Other Study ID Numbers: | PIM4604g, MP00880 |
| Study First Received: | February 27, 2009 |
| Last Updated: | May 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
NHL Tumors Carcinogenic Tumors |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |