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COMPLETEDPHASE1/PHASE2

Dose-finding Study in Platinum-Resistant Ovarian Cancer

An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer

NCT01653912•Accenture

View on ClinicalTrials.gov

Summary

* Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer. * Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.

Detailed Description

PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female, 18 years of age as of signing the informed consent form, capable of giving/complying with written informed consent
•Histologically or cytologically confirmed serous ovarian cancer (includes primary peritoneal and Fallopian tube)
•Negative serum pregnancy test in women of childbearing potential within 14 days of first dose of treatment, agree to use effective contraception during/after (6 months post dose of paclitaxel or 30 days post dose GSK2110183 whichever is longer)
•Performance Status score of 0-2 according to the ECOG scale.
•Able to swallow and retain oral medication
•Subjects diagnosed previously with Type 2 diabetes must have been diagnosed ≥ 6 months prior to enrollment
•Prior treatment-related toxicities (except for alopecia) must be ≤ Grade 1 according to NCI-CTCAE (Version 4.0 \[NCI, 2009\]) at the time of treatment allocation OR ≤ Grade 2 and stable for 4 weeks or longer at the time of screening evaluation. Exception: Subjects with peripheral neuropathy \>/= Grade 2 will NOT be eligible
•Adequate organ system function
•Cohort A
•Phase I criteria
+11 more criteria

Exclusion Criteria

•History of another malignancy (some exceptions may apply)
•Serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
•Current use of prohibited medication during treatment.
•Chemotherapy, immunotherapy, or other anti-cancer therapy within 14 days prior to the first dose study drug
•Radiotherapy prior to initiation of therapy (some exceptions may apply)
•Contraindications (identified by the investigator) to the doses of carboplatin and/or paclitaxel
•History of reduction in standard of care paclitaxel dose for peripheral neuropathy
•No known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar or related to GSK2110183
•No known delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar to carboplatin or paclitaxel (some exceptions may apply)
•Prior use of a drug that targets AKT including perifosine
+13 more criteria

Locations (10)

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Western Hospital

Footscray, Victoria, Australia

Royal Women's Hospital

Parkville, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Medical Radiology Scientific Center of Ministry of Healthcare and Social Development of RF

Omskaya, Russia

City Clinical Oncology Dispensary

Saint Petersburg, Russia

Mount Vernon Cancer Center

Northwood, Middlesex, London, United Kingdom

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surry, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Key Dates

Start Date

November 1, 2012

Primary Completion Date

July 1, 2015

Completion Date

November 1, 2015

Last Updated

April 2, 2018

Enrollment

ACTUAL participants

Conditions

Recurrent Platinum-resistant Ovarian Cancer

Interventions

GSK2110183 in combination with carboplatin and paclitaxel

DRUG

Camrelizumab /Apatinib for Recurrent Platinum-resistant Ovarian Cancer

NCT04068974

Recurrent Platinum-resistant Ovarian Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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