Status:
COMPLETED
Dose-Escalation Study of GSK2126458
Lead Sponsor:
GlaxoSmithKline
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 GSK212645...
Detailed Description
This study is a Phase I, first-time-in-human dose escalation study in subjects with refractory solid tumors or lymphoma. The primary objective of this study is to determine the recommended Phase II do...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2015
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00972686
Start Date
August 31 2009
End Date
March 31 2015
Last Update
May 9 2017
Active Locations (9)
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1
GSK Investigational Site
San Francisco, California, United States, 94115
2
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
3
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
4
GSK Investigational Site
Dallas, Texas, United States, 75246