Condition category
Cancer
Date applied
16/01/2014
Date assigned
16/01/2014
Last edited
14/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 controlled trial

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

Sponsor information

Organisation

Imperial College of Science, Technology and Medicine (UK)

Sponsor details

Department of Cancer Medicine
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes