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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00920257 |
Purpose
This study is a first time in human, Phase I, open-label, dose-escalation study of the oral AKT inhibitor GSK2141795 in subjects with solid tumors or lymphomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors and Lymphoma Cancer |
Drug: GSK2141795 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-Label, Two-Stage Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Oral AKT Inhibitor GSK2141795 in Subjects With Solid Tumors or Lymphomas |
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GSK2141795
Oral GSK214179 given daily to patients with cancer. Groups of approximately three patients will receive GSK2141795 at increasing doses until a maximum tolerated dose is identified.
|
Drug: GSK2141795
GSK2141795 is an oral AKT inhibitor.
|
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| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10021 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00920257 History of Changes |
| Other Study ID Numbers: | 112689 |
| Study First Received: | June 12, 2009 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
|
oncology breast cancer AKT inhibitor first time in human |
lymphoma endometrial cancer GSK2141795 solid tumors |
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |