Last updated: 11/03/2018 14:17:54
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
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
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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
Trial description: The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689 for the same schedule.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
The amount of GSK2141795 in the blood (ng/ml) from baseline
Timeframe: 6 months
Secondary outcomes:
The net unidirectional uptake of FDG (Ki) from baseline
Timeframe: 6 months
The change in size of tumor from baseline (RECIST Criteria)
Timeframe: 6 months
Interventions:
Enrollment:
36
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Solid Tumours
Product
uprosertib
Collaborators
GSK
Study date(s)
June 2010 to September 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
18 - 85 years
Accepts healthy volunteers
No
- 1. Capable of giving written informed consent
- 2. Females of non-childbearing potential, 18 years or older with ovarian cancer
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2011-01-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 113124 can be found on the GSK Clinical Study Register.
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