Last updated: 11/03/2018 17:38:37
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects with Solid Tumors and Hematologic Malignancies
GSK study ID
115131
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects with Solid Tumors and Hematologic Malignancies
Trial description: GSK2110183 is an orally administered, pan-AKT kinase inhibitor that has demonstrated nonclinical activity in hematologic as well as solid tumor cell lines and xenograft models. In the First Time In Human (FTIH) trial, monotherapy with GSK2110183 dosed orally, once daily has shown encouraging activity in subjects with hematologic malignancies. This multicenter, non-randomized, open-label, treatment continuation or ‘rollover’ study is designed to provide continued access to eligible subjects who have previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects must be receiving clinical benefit from continued treatment and have an acceptable safety profile with GSK2110183. Subjects who have participated in a GSK2110183 combination study with an approved anti-cancer agent will also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) will not be eligible for this rollover study. Subjects will be enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) will be evaluated during this study. Disease assessment will be performed using local standard of care imaging practices and criteria appropriate for disease type and location.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
vital signs
Timeframe: 6 months
Adverse Events
Timeframe: 6 months
laboratory values
Timeframe: 6 months
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
200
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
afuresertib, uprosertib
Collaborators
Not applicable
Study date(s)
February 2012 to December 2017
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18 - 80 Year
Accepts healthy volunteers
none
- Has provided signed informed consent for this study.
- Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
- Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression.
- Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
Inclusion and exclusion criteria
Inclusion criteria:
- Has provided signed informed consent for this study.
- Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
- Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen.
- Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK2110183.
- Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 weeks after the last dose of GSK2110183.
- Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
- Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale
- Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry.
- Have adequate organ system function
Exclusion criteria:
- Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression.
- Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
- Local access to commercially available GSK2110183.
- Current use of a prohibitive medication(s)
- Current use of anticoagulants
- Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study.
- History of HIV infection.
- Peripheral neuropathy greater than Grade 1
- History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted).
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease).
- QTcF interval greater than 500 msecs at the time of transition to this study.
- Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
- Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study.
- Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study.
- Lactating female or female who becomes pregnant prior to transition to this study.
- Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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