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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2141795 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2141795 | Drug | GSK2141795 is an oral AKT inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the recommended Phase II dose and schedule of GSK214179 using the following information: safety and tolerability, pharmacokinetic (single and repeat dose administration) and pharmacodynamic data | Continune until disease progression or consent withdrawn |
| Measure | Description | Time Frame |
|---|---|---|
| • To explore the clinical efficacy of GSK2141795 in subjects with solid tumor malignancies or lymphomas | Continune until disease progression or consent withdrawn | |
| To characterize the metabolite profile of oral GSK2141795 after repeat dose administration in subjects with solid tumor malignancies or lymphoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Baltimore | Maryland | 21231-2410 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29611022 | Derived | Aghajanian C, Bell-McGuinn KM, Burris HA 3rd, Siu LL, Stayner LA, Wheler JJ, Hong DS, Kurkjian C, Pant S, Santiago-Walker A, Gauvin JL, Antal JM, Opalinska JB, Morris SR, Infante JR. A phase I, open-label, two-stage study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the oral AKT inhibitor GSK2141795 in patients with solid tumors. Invest New Drugs. 2018 Dec;36(6):1016-1025. doi: 10.1007/s10637-018-0591-z. Epub 2018 Apr 3. |
| Label | URL |
|---|---|
| Results for study 112689 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000595149 | GSK2141795 |
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| Continune until disease progression or consent withdrawn |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| D009370 |
| Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |