- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666081
Study to Investigate AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic Malignancies
April 15, 2015 updated by: GlaxoSmithKline
A Phase I Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Potential Anti-cancer Activity of the AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic Malignancies
This is a two-part study in subjects with hematologic malignancies designed to find the maximum tolerated dose (MTD) of GSK690693 (Part 1).
Part 2 is designed to determine the efficacy of GSK690693 in a subset of subjects with hematologic malignancies.
Study Overview
Study Type
Interventional
Phase
- Phase 1
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:
- Histologically- or cytologically-confirmed diagnosis of a hematologic malignancy that has relapsed or is refractory after standard therapy, AND that is not associated with human immunodeficiency virus (HIV) infection or solid organ transplant.
- Signed written consent provided.
- At least 18 years of age.
- A woman is eligible to enter and participate in the study if she is of: Non-childbearing potential , or is post-menopausal .
- A man with a female partner of childbearing potential is eligible to enter and participate in the study if he has either had a prior vasectomy or agrees to use adequate contraception (as described above) during the study, and up to 3 months after last dose of study drug.
- Fasting glucose that is not elevated.
- Laboratory values within ranges defined in the protocol
Exclusion Criteria:
- Previously diagnosed diabetes mellitus (type 1 or 2), or gestational diabetes.
- Symptomatic or untreated central nervous system (CNS) involvement by the hematologic malignancy (including primary CNS lymphoma). Subjects who were previously treated for CNS involvement, and are asymptomatic without anti-epileptic medications or steroids for at least 2 months are eligible.
- Subjects who have undergone an allogeneic stem cell transplant.
- Unresolved toxicity from previous anti-cancer therapy as agreed to by Medical Monitor and the Investigator,.
- Major surgery within the past 28 days.
- Chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy within 21 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of study medication. For subjects with acute leukemia, anti-cancer chemotherapy (including corticosteroids) may be administered up to 7 days prior to the first dose of study medication. Chemotherapy given at a dose and schedule that is not expected to have delayed toxicity can be given with an interval of 14 days or more from the first dose. Hydroxyurea may be administered up to 7 days prior to the first dose of study medication.
- Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids.
- Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
- Any female who is pregnant or lactating.
- 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.
- Significant ECG abnormalities.
- Use of medications known to prolong the QTc interval within 14 days (or 5 half-lives) prior to the first dose of study medication.
- History of myocardial infarction, acute coronary syndromes, unstable angina or coronary angioplasty/stenting/bypass grafting within the past 6 months.
- Left ventricular ejection fraction (LVEF) less than 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scanning.
- Use of theophylline within 14 days of the first dose of study medication.
- Current use of warfarin ≥4 mg per day; however, low molecular weight heparin and prophylactic low-dose warfarin are permitted, if PT/PTT < 1.2 x ULN.
- Concurrent condition that in the Investigator's opinion would jeopardize the subject's ability to comply with the protocol.
- History of allergic reactions attributed to compounds of similar chemical composition to GSK690693.
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: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
GSK690693 for injection.
This is a dose escalation study.
|
Administered intravenously at a concentration between 0.1 - 4.8 mg/mL by slow infusion over 4 h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize a range of doses and to identify the MTD of GSK690693 when dosed daily for 5 consecutive days every 21 days as an IV infusion over 4 h.
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma pharmacokinetic parameters of GSK690693. To evaluate the response of refractory hematologic malignancies to treatment with GSK690693.
Time Frame: 21 days
|
21 days
|
Blood levels of GSK690693 to derive pharmacokinetic parameters
Time Frame: 21 days
|
21 days
|
Tumor responses
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2008
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 22, 2008
First Posted (Estimate)
April 24, 2008
Study Record Updates
Last Update Posted (Estimate)
April 17, 2015
Last Update Submitted That Met QC Criteria
April 15, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKT108169
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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