An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer

Inclusion criteria

• Capable of giving written informed consent
• Females of non-childbearing potential, 18 years or older with ovarian cancer
• Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer
• Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent uterine or gastro-oesophageal tumors (these tumor types will only be included if there is poor enrollment of patients with ovarian cancer)
• Disease at least 2 cm suitable for assessment by imaging
• Performance Status score of 0, 1 or 2 according to the Eastern Cooperative Oncology Group scale
• Adequate organ systems function

Exclusion criteria

• Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose of GSK2141795
• Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK2141795
• Current use of a prohibited medication
• Anticoagulants at therapeutic doses are permitted only after consultation with the GSK Medical Monitor
• Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption
• Any major surgery within the last four weeks of screening
• Unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy
• Previously diagnosed diabetes mellitus
• Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids
• Any serious or unstable pre-existing medical, psychiatric, or other condition
• Symptomatic or untreated CNS metastases or leptomeningeal involvement
• Evidence of severe or uncontrolled systemic diseases
• QTc interval ≥ 470 msecs
• Other clinically significant ECG abnormalities
• History of myocardial infarction, acute coronary syndromes
• Class III or IV heart failure
• Pregnant or Lactating patients
• History of hepatitis B or C or HIV