Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01266954
Other study ID # 113124
Secondary ID
Status Completed
Phase Phase 1
First received October 21, 2010
Last updated November 7, 2017
Start date June 1, 2010
Est. completion date September 1, 2011

Study information

Verified date November 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 1, 2011
Est. primary completion date September 1, 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GSK2141795
GSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models

Locations

Country Name City State
United Kingdom GSK Investigational Site London

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The amount of GSK2141795 in the blood (ng/ml) from baseline 6 months
Secondary The net unidirectional uptake of FDG (Ki) from baseline 6 months
Secondary The change in size of tumor from baseline (RECIST Criteria) 6 months
See also
  Status Clinical Trial Phase
Completed NCT03315091 - Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours Phase 1
Completed NCT01921140 - To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours Phase 1
Completed NCT00732420 - Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors Phase 1
Recruiting NCT03572192 - Tissue Collection Framework To Improve Outcomes In Solid Tumours
Completed NCT02360345 - Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly Phase 1
Completed NCT02264418 - Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours Phase 1
Completed NCT02093351 - To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer Phase 1
Completed NCT01956669 - Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors Phase 2
Recruiting NCT02215850 - Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours Phase 1
Recruiting NCT02263950 - A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours Phase 1/Phase 2
Completed NCT01931761 - Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers Phase 1
Completed NCT01900028 - To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours Phase 1
Completed NCT00136578 - Ispinesib In Combination With Carboplatin In Patients With Solid Tumors Phase 1
Completed NCT01184274 - A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia Phase 1
Withdrawn NCT03266159 - A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors Phase 2
Active, not recruiting NCT01894256 - Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function Phase 1
Completed NCT01974349 - To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers Phase 1
Completed NCT02923947 - Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment Phase 1
Completed NCT02063204 - To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects Phase 1
Completed NCT02056392 - To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers Phase 1