Know Cancer

or
forgot password

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


Phase 1
18 Years
85 Years
Not Enrolling
Female
Solid Tumours

Thank you

Trial Information

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:



1. Capable of giving written informed consent

2. Females of non-childbearing potential, 18 years or older with ovarian cancer

3. Histologically or cytologically confirmed diagnosis of PET-positive recurrent or
persistent ovarian cancer

4. 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)

5. Disease at least 2 cm suitable for assessment by imaging

6. Performance Status score of 0, 1 or 2 according to the Eastern Cooperative Oncology
Group scale

7. Adequate organ systems function

Exclusion Criteria:

1. Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose
of GSK2141795

2. Use of an investigational anti-cancer drug within 28 days or five half-lives,
whichever is shorter, prior to the first dose of GSK2141795

3. Current use of a prohibited medication

4. Anticoagulants at therapeutic doses are permitted only after consultation with the
GSK Medical Monitor

5. Presence of active gastrointestinal disease or other condition that could affect
gastrointestinal absorption

6. Any major surgery within the last four weeks of screening

7. Unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer
therapy

8. Previously diagnosed diabetes mellitus

9. Current use of oral corticosteroids, with the exception of inhaled or topical
corticosteroids

10. Any serious or unstable pre-existing medical, psychiatric, or other condition

11. Symptomatic or untreated CNS metastases or leptomeningeal involvement

12. Evidence of severe or uncontrolled systemic diseases

13. QTc interval ≥ 470 msecs

14. Other clinically significant ECG abnormalities

15. History of myocardial infarction, acute coronary syndromes

16. Class III or IV heart failure

17. Pregnant or Lactating patients

18. History of hepatitis B or C or HIV

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The amount of GSK2141795 in the blood (ng/ml) from baseline

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

113124

NCT ID:

NCT01266954

Start Date:

June 2010

Completion Date:

September 2011

Related Keywords:

  • Solid Tumours
  • Cancer
  • 18F FDG
  • PK
  • PET
  • Positron Emission Tomography
  • PD
  • AKT Inhibitor
  • GSK2141795
  • Ovarian Neoplasms

Name

Location