Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT01653912
Eligibility Criteria:
Phase I 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
Phase II Inclusion Criteria:
Cohort A
* Phase I criteria
* Documented complete or partial response by RECIST to at least 1 prior platinum-based therapy
* Progression defined by either (1) RECIST v1.1 criteria or (2) GCIG CA 125 criteria associated with symptoms necessitating treatment between 1 and 6 months of prior platinum-based therapy either in adjuvant or metastatic setting
* Subjects allowed to have a maximum of one non-platinum-based therapy between the onset of platinum resistance
* Must have radiologically measurable disease i.e. presenting with at least one measurable lesion per RECIST 1.1
Cohort B
* Phase I criteria
* Documented complete or partial response by RECIST to at least 1 prior platinum-based therapy
* Progression defined by either (1) RECIST v1.1 criteria or (2) GCIG CA 125 criteria associated with symptoms necessitating treatment while being treated with a regimen containing carboplatin and paclitaxel (or within 4 weeks of completing treatment)
* Subjects will be required to start on treatment within 8 weeks after the last infusion of chemotherapy and may not have had any other anti-cancer therapy in the intervening time
* Must have radiologically measurable disease i.e. presenting with at least one measurable lesion per RECIST 1.1
* Additional restrictions on number of prior therapies may be added to eligibility criteria based on emerging data
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
* History of Type 1 diabetes
* Gastrointestinal disease or other condition that could affect absorption or predispose subject to gastrointestinal ulceration
* Mucosal or internal bleeding
* Major surgery within the last four weeks
* Infection requiring parenteral or oral anti-infective treatment
* Severe or uncontrolled systemic diseases
* Brain metastases and/or leptomeningeal disease
* QTcF interval ≥ 470 msecs
* Bundle branch block, pacemaker or clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block
* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty,stenting or bypass grafting within six months of Screening
* Class II, III or IV heart failure as defined by the NYHA functional classification system
* Pregnant or lactating female
* Malignancies related to HIV or solid organ transplant; history of known HIV, history of know HBV surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive HCV antibody
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01653912
Study Brief:
Protocol Section:
NCT01653912