RecruitingPhase 2ACTRN12613000048785

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


Sponsor

Royal Women's Hospital

Enrollment

60 participants

Start Date

Nov 23, 2012

Study Type

Interventional

Conditions

Summary

This is a biological study, which aims to answer novel questions about the molecular status of cells from patients with platinum-resistant ovarian cancer before and after treatment with the AKT inhibitor GSK2110183 given in combination with chemotherapy (in the accompanying PKB116611 study). We will biopsy tumour tissue and collect blood samples from PKB116611 participants with platinum resistant ovarian cancer prior to and following treatment in order to perform the following studies on tissue samples: 1) Immunohistochemical, ELISA and protein array (RPPA) based analysis of tumour biopsies for markers such as AKT, pAKT, PRAS40, pPRAS40, Ki67, LARP1 and multiple components of the extended AKT pathway 2) Genomic analysis of archived tumour samples for mutations in known cancer genes by Sequenom OncoMap assays. 3) Analysis of blood-derived markers in circulating tumour cells (CTCs), peripheral blood mononuclear cells (PBMCs) and plasma. 4) Analysis (where appropriate) of ascites (or pleural effusion) for markers such as AKT, pAKT, PRAS40, pPRAS40, Ki67 and LARP1.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is collecting tissue and blood samples from women with platinum-resistant ovarian cancer who are receiving an experimental drug called GSK2110183 (an AKT inhibitor) alongside chemotherapy. Platinum-resistant means the cancer came back or kept growing within 6 months of standard chemotherapy. By analyzing the samples, researchers hope to understand why some tumors respond to this treatment and others do not — and identify markers that could guide future treatment decisions. You may be eligible if: - You are female and 18 years or older - You have platinum-resistant ovarian cancer (cancer that progressed within 6 months of platinum chemotherapy) - You have a tumor large enough to biopsy (at least 2 cm) - You are already eligible for the linked treatment trial (PKB116611) You may NOT be eligible if: - You are currently taking warfarin or low molecular weight heparin (heparin is acceptable if stopped for 2 days before the biopsy) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

As part of the main study, patients will initially undergo certain tests and scans to make sure that the study is right for them. During this time, three extra 10ml tubes of blood (30ml, 6-8 teaspoon

As part of the main study, patients will initially undergo certain tests and scans to make sure that the study is right for them. During this time, three extra 10ml tubes of blood (30ml, 6-8 teaspoons) will be taken for this sub-study. During routine blood tests before each cycle of chemotherapy and maintenance phase of the GSK2110183 drug (see main study details below), an extra 30mls of blood will be collected. At the end of the study, a final 30mls of blood will also be collected. Patients will also be asked to have a biopsy of their tumour before starting treatment (chemotherapy) and during treatment. The biopsies will give the researchers information about how the drug works and help to develop tests that predict who might respond to treatment. The tests involve looking at the molecules in the tumour tissue. Biopsies will be done only if it is easy to perform with minimal discomfort to participants. This will be done as a day case at the hospital after using a local numbing medicine to allow painless biopsy from the area by an experienced radiologist. The second biopsy is optional. Addditionally, at any point during the study, should a participant require a clinical procedure to remove fluid from their abdomen, researchers would like to store some of the fluid which would otherwise be disposed of. To see details of the main study please go to; http://www.clinicaltrials.gov/ct2/show/NCT01653912?term=NCT01653912&rank=1


Locations(3)

Peter MacCallum Cancer Institute - East Melbourne

VIC, Australia

The Royal Women's Hospital - Parkville

VIC, Australia

London, United Kingdom

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ACTRN12613000048785