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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01531894




Registration number
NCT01531894
Ethics application status
Date submitted
9/02/2012
Date registered
13/02/2012
Date last updated
9/07/2019

Titles & IDs
Public title
Continuation Study of the Oral AKT Inhibitor GSK2110183
Scientific title
An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies
Secondary ID [1] 0 0
2014-002041-22
Secondary ID [2] 0 0
115131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK2110183 (afuresertib)

Experimental: GSK2110183 (afuresertib) - All patients received the GSK2110183 (afuresertib) treatment


Treatment: Drugs: GSK2110183 (afuresertib)
Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With at Least One Adverse Events (AEs)
Timepoint [1] 0 0
from the time of consent until the final study visit up to approx. 76 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2018
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Ireland
State/province [5] 0 0
Galway
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was
designed to provide continued access to eligible subjects who had previously participated in
a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research
organization working on behalf of GSK. Eligible subjects had previously received clinical
benefit from continued treatment and had to have ad an acceptable safety profile with
GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved
anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who
participated in combination studies with two investigational compounds (one being GSK2110183)
were not eligible for this rollover study. Subjects were 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) were evaluated during this study. Disease assessment were performed using local
standard of care imaging practices and criteria appropriate for disease type and location.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01531894
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01531894