Continuation Study of the Oral AKT Inhibitor GSK2110183

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01531894
First received: February 9, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: GSK2110183
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • laboratory values [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • vital signs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
subjects who have completed less than 24 weeks of treatment with GSK2110183 monotherapy
Drug: GSK2110183
an oral, low nanomolar pan-AKT kinase inhibitor
Experimental: Arm 2
subjects who have completed greater than 24 weeks of treatment with GSK2110183 monotherapy
Drug: GSK2110183
an oral, low nanomolar pan-AKT kinase inhibitor
Experimental: Arm 3
subjects who have participated in a combination study where GSK2110183 is administered with an approved anti-cancer agent, regardless of duration
Drug: GSK2110183
an oral, low nanomolar pan-AKT kinase inhibitor

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531894

Contacts
Contact: US GSK Clinical Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Australia, Victoria
GSK Investigational Site Recruiting
Melbourne, Victoria, Australia, 3004
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, Ontario
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 1Z6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Korea, Republic of
GSK Investigational Site Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01531894     History of Changes
Other Study ID Numbers: 115131
Study First Received: February 9, 2012
Last Updated: July 24, 2014
Health Authority: Canada: Health Products and Foods Branch, Health Canada
Australia: Human Research Ethics Committee
United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
solid tumor
GSK2110183
hematologic malignancy
AKT inhibitor
cancer
safety

ClinicalTrials.gov processed this record on September 30, 2014