Study to see if GSK2110183 with chemotherapy can treat ovarian cancer
| ISRCTN | ISRCTN22893535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22893535 |
| EudraCT/CTIS number | 2012-002483-27 |
| ClinicalTrials.gov number | NCT01653912 |
| Secondary identifying numbers | 13614, PKB116611 |
- Submission date
- 16/01/2014
- Registration date
- 16/01/2014
- Last edited
- 14/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Maria Martinez
Scientific
Scientific
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Maria.martinez@imperial.nhs.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Process of Care, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | AKTRES |
| Study objectives | 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(s) | London Hampstead, 07/11/2012, ref. 12/LO/1174 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube |
| Intervention | Blood sampling, [3 x 10 ml 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 10 ml 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | GSK2110183 (afurasertib) |
| Primary outcome measure | 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 study start date | 10/12/2012 |
| Completion date | 04/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 24; UK Sample Size: 12 |
| Total final enrolment | 59 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 10/12/2012 |
| Date of final enrolment | 04/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Imperial College of Science, Technology and Medicine (UK)
University/education
University/education
Department of Cancer Medicine
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Charity
Ovarian Cancer Action (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | No | No | |||
| Results article | 01/03/2019 | 14/04/2021 | Yes | No |
Editorial Notes
14/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT number and EudraCT numbers have been added.
4. The basic results links have been added.
5. Afuresertib has been added to the drug names.
6. The trial phase has been added.
08/02/2017: No publications found in PubMed, verifying study status with principal investigator.
