Dose-Escalation Study of GSK2126458
FTIH
A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK2126458 in Subjects With Solid Tumors or Lymphoma
1 other identifier
interventional
79
2 countries
9
Brief Summary
P3K112826 is a Phase I, first-time-in-human dose escalation study in subjects with refractory malignancy. The primary objective of this study is to determine the recommended Phase II dose of GSK2126458 based on safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary evidence of clinical activity. Secondary objectives are to characterize the pharmacokinetics of GSK2126458; and to explore relationships between GSK2126458 pharmacokinetics, pharmacodynamics, response prediction biomarkers and clinical endpoints.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2009
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2009
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2015
CompletedMay 9, 2017
May 1, 2017
3.3 years
September 3, 2009
May 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs) and changes in laboratory values and vital signs. Pharmacokinetic parameter values for GSK2126458, Change from baseline in protein markers in tumor and/or blood. Blood glucose and insulin levels. Tumor response, RECIST defined
Subjects continue on study until disease progression or consent withdrawal
Secondary Outcomes (1)
Metabolic profile in plasma at the maximum tolerated dose
Subjects continue on study until disease progression or consent withdrawal
Study Arms (1)
GSK2126458
EXPERIMENTALGSK2126458 will be dosed continuously (every day) for the duration a 28 day cycle. The 28 day cycles will continue until the subjects withdraw from the study.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically- or cytologically- confirmed diagnosis of solid tumor malignancy, or lymphoma
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Female or male that is willing to take measures to avoid pregnancy in self or a partner, including abstinence, or double barrier method.
- Adequate organ system function
You may not qualify if:
- Use of an investigational anti-cancer medication within 28 days or 5 half-lives preceding the first dose of GSK2126458.
- Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C
- Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
- Prior use of any PI3K inhibitor.
- Current use of a prohibited medication or requires any of these medications during treatment with GSK2126458.
- Presence of an active gastrointestinal disease or other condition known to interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
- Unresolved toxicity greater than Grade 1 from previous anti-cancer therapy except alopecia.
- QTc interval ≥ 480 msecs.
- History of acute coronary syndromes; Class II, III, or IV heart failure; stroke or subarachnoid hemorrhage.
- Systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.
- Previously diagnosed Type 1 diabetes mellitus. Subjects with Type 2 diabetes are prohibited in the dose escalation part of the study.
- Symptomatic or untreated leptomeningeal or brain metastases.
- Primary malignancy of the central nervous system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (9)
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
New Brunswick, New Jersey, 08901, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7600, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Salt Lake City, Utah, 84112-5550, United States
GSK Investigational Site
Seattle, Washington, 98109, United States
GSK Investigational Site
Amsterdam, 1066 CX, Netherlands
GSK Investigational Site
Utrecht, 3584 CX, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 7, 2009
Study Start
August 31, 2009
Primary Completion
December 12, 2012
Study Completion
March 31, 2015
Last Updated
May 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.