Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Maria Martinez
ORCID ID
Contact details
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
-
Maria.martinez@imperial.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13614, PKB116611
Study information
Scientific title
AKTRES study: A Biologic Study of the early effects and determinants of AKT inhibition using GSK2110183 alongside chemotherapy in patients with platinum RESistant adenocarcinoma of the ovary
Acronym
AKTRES
Study hypothesis
Activation of the AKT signalling pathway in ovarian cancer cells causes chemotherapy resistance. An AKT inhibitor, given alongside chemotherapy, could potentially reverse this resistance and enable chemotherapy to be effective once again. This study is designed for women whose ovarian cancer has relapsed within 6 months of receiving carboplatin or cisplatin-containing chemotherapy and who are receiving an AKT inhibitor given alongside 3 weekly carboplatin and paclitaxel in the PKB116611 trial. Participants in the AKTRES study undergo a maximum of two biopsies from their tumour and some additional blood tests. The aims of the study are to better understand the how chemotherapy-resistant cancer cells are affected by AKT inhibitors.
Ethics approval
London Hampstead, 07/11/2012, ref. 12/LO/1174
Study design
Non-randomised; Interventional; Design type: Process of Care, Treatment
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube
Intervention
Blood sampling, [3x 10mls whole blood collected in greentopped (heparinised) tube] will be collected at baseline (within 14 days prior to first dose), on day 1 (immediately preceding chemotherapy), day 8 and day 15 of cycle 1 only. Blood sampling will subsequently be performed at day 1 only of subsequent chemotherapy treatment cycles and thereafter 3 weekly for those on maintenance GSK2110183 alone. A final 3 x 10mls blood sample will be taken at end of study visit.
Coagulation profile, will be collected immediately prior to the first biopsy during the screening period and postcycle 1 biopsy on day 22. This is in addition to the screening coagulation blood test required for PKB116611 study.
Collection of ascites: If patients are undergoing ascitic or pleural drainage for symptom relief prior to, or during, this study a sample of ascites (or pleural effusion) can be taken and stored. The preferred times for collection are during screening, day 22 and at study completion, but additional/alternative collections can be obtained at the investigatorsÂ’ discretion.
Tumour Biopsy: A tumour biopsy performed under image guidance within 14 days prior to first dose. Three tumour cores will be taken, two will be fresh frozen and one will be formalin fixed. Following one complete treatment cycle (day 22), =3 days prior to starting cycle 2 day 1, a second tumour biopsy will be performed under image guidance. Again, three tumour cores will be taken, two will be fresh frozen and one will be formalin fixed. Patients can decline the second biopsy if they wish to.
Intervention type
Drug
Phase
Not Applicable
Drug names
GSK2110183
Primary outcome measures
Overall Response, CA125 response and Progression free survival measured by ELISA detected decrease in phosphorylated PRAS40 (as ratio of total PRAS40) and increase in pAKT S473
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/12/2012
Overall trial end date
04/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female at least 18 years of age at the time of signing the informed consent form
2. Capable of giving written informed consent
3. Having measurable tumour tissue and Platinum-resistant ovarian cancer as defined as radiological evidence of disease progression within 6 months of completion of platinum-containing chemotherapy
4. Tumour tissue measuring >2cm long axis amenable to direct biopsy or biopsy via image-guidance
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 24; UK Sample Size: 12
Participant exclusion criteria
Concurrent medication with warfarin or low molecular weight heparin (heparin use is acceptable if it has been discontinued for 2 days preceding biopsy)
Recruitment start date
10/12/2012
Recruitment end date
04/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
Funders
Funder type
Charity
Funder name
Ovarian Cancer Action (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary