- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00920257
A Phase I, Open-Label, First-Time-In-Human Study of the Oral AKT Inhibitor GSK2141795
November 8, 2017 updated by: GlaxoSmithKline
A Phase I, Open-Label, Two-Stage Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Oral AKT Inhibitor GSK2141795 in Subjects With Solid Tumors or Lymphomas
This study is a first time in human, Phase I, open-label, dose-escalation study of the oral AKT inhibitor GSK2141795 in subjects with solid tumors or lymphomas.
Study Overview
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- GSK Investigational Site
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New York
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New York, New York, United States, 10021
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, United States, 37203
- GSK Investigational Site
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Texas
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Houston, Texas, United States, 77030
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Male or female, 18 years or older.
- Histologically or cytologically confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved or curative therapy. Subjects with malignancies related to human immunodeficiency virus (HIV) or solid organ transplant are excluded.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Able to swallow and retain oral medication.
- Fasting serum glucose <126 mg/dL.
- Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use adequate contraception from the time of the first dose of GSK2141795 until three months after the last dose of GSK2141795.
- A female subject is eligible to participate if she is of non-child bearing potential, or of child-bearing potential and willing to use adequate birth control
- Adequate organ function
- (Part 2 only - endometrial) Histologically or cytologically confirmed diagnosis of relapsed or metastatic endometrial cancer.
- (Part 2 only - endometrial) No more than two prior cytotoxic chemotherapy regimens in the relapsed or metastatic setting. Targeted agents like bevacizumab are not considered cytotoxic chemotherapy for the purposes of this study
- (Part 2 only, breast) Histologically or cytologically confirmed diagnosis of locally advanced or metastatic breast cancer.
- (Part 2 only, breast) No more than three prior cytotoxic chemotherapy regimens in the metastatic setting. Targeted agents like lapatinib, bevacizumab, and trastuzumab are not considered cytotoxic chemotherapy for the purposes of this study
Exclusion Criteria:
- Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of GSK2141795. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity are permitted with approval of a GSK Medical Monitor if dosing of that chemotherapy is terminated at least 14 days prior to the first dose of GSK2141795.
- Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is longer, preceding the first dose of GSK2141795.
- Current use of a prohibited medication or requires any of these medications during treatment with GSK2141795.
- Current use of anticoagulants at therapeutic levels within seven days prior to the first dose of GSK2141795, including warfarin, low molecular weight heparin and direct thrombin inhibitors. Low dose (prophylactic) anticoagulants such as warfarin, low molecular weight heparin, selective Factor Xa inhibitors or direct thrombin inhibitors are permitted provided that subject's PT and PTT meet entry criteria.
- Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption (e.g. malabsorption syndrome) or predispose a subject to gastrointestinal ulceration.
- Current use of any anti-platelet agent (e.g. dipyridamole, clopidogrel) other than aspirin (81 mg daily).
- Any major surgery within the last four weeks of screening.
- Unresolved toxicity (except alopecia) greater than or equal to Grade 2 from previous anti-cancer therapy unless agreed to by a GSK Medical Monitor and the investigator, and where a GSK Medical Monitor and the investigator consider that the ongoing toxicity will not introduce additional risk factors and will not interfere with the study procedures.
- Previously diagnosed diabetes mellitus (type 1 or 2).
- Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids.
- History of an allogeneic stem cell transplant. Subjects with a history of an autologous stem cell transplant are NOT excluded.
- Any serious or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or with obtaining informed consent.
- Symptomatic or untreated CNS metastases or leptomeningeal involvement. Subjects who were previously treated for these conditions, and are asymptomatic without anti-epileptic medications or steroids for at least 2 months are eligible. Subjects with primary brain tumor are excluded.
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).
- QTc interval greater than or equal to 470 msecs.
- Other 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, or stenting or bypass grafting within the past 6 months.
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Pregnant or Lactating females.
- History of HIV infection; history of hepatitis B or C (subject with evidence of cleared hepatitis B are eligible)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GSK2141795
Oral GSK214179 given daily to patients with cancer.
Groups of approximately three patients will receive GSK2141795 at increasing doses until a maximum tolerated dose is identified.
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GSK2141795 is an oral AKT inhibitor.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the recommended Phase II dose and schedule of GSK214179 using the following information: safety and tolerability, pharmacokinetic (single and repeat dose administration) and pharmacodynamic data
Time Frame: Continune until disease progression or consent withdrawn
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Continune until disease progression or consent withdrawn
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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• To explore the clinical efficacy of GSK2141795 in subjects with solid tumor malignancies or lymphomas
Time Frame: Continune until disease progression or consent withdrawn
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Continune until disease progression or consent withdrawn
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To characterize the metabolite profile of oral GSK2141795 after repeat dose administration in subjects with solid tumor malignancies or lymphoma
Time Frame: Continune until disease progression or consent withdrawn
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Continune until disease progression or consent withdrawn
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2009
Primary Completion (Actual)
April 17, 2013
Study Completion (Actual)
April 17, 2013
Study Registration Dates
First Submitted
June 12, 2009
First Submitted That Met QC Criteria
June 12, 2009
First Posted (Estimate)
June 15, 2009
Study Record Updates
Last Update Posted (Actual)
November 13, 2017
Last Update Submitted That Met QC Criteria
November 8, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 112689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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