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An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Cancer

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Trial Information

An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Canada: Health Products and Foods Branch, Health Canada

Study ID:

115131

NCT ID:

NCT01531894

Start Date:

February 2012

Completion Date:

January 2016

Related Keywords:

  • Cancer
  • solid tumor
  • GSK2110183
  • hematologic malignancy
  • AKT inhibitor
  • cancer
  • safety
  • Hematologic Neoplasms

Name

Location

GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteNew York, New York  10021