Dose-Escalation Study of GSK2126458

Completed · Phase 1

Conditions studied: Solid Tumours

In brief

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.

Key facts

Study ID

NCT00972686

Run by

GlaxoSmithKline

People needed

79

Starts

2009-08-31

Expected to finish

2015-03-31

Last updated by the study team

2017-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Amsterdam, Netherlands
• GSK Investigational Site — Utrecht, Netherlands
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — New Brunswick, New Jersey, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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