Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK2126458 in Subjects with Solid Tumors or Lymphoma
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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
Timeframe: Subjects continue on study until disease progression or consent withdrawal
Secondary outcomes:
Metabolic profile in plasma at the maximum tolerated dose
Timeframe: Subjects continue on study until disease progression or consent withdrawal
Interventions:
Drug: GSK2126458
Enrollment:
79
Observational study model:
Not applicable
Primary completion date:
2012-12-12
Time perspective:
Not applicable
Clinical publications:
Munster P, Aggarwal R, Hong D, Schellens J, van der Noll R, Specht J, Witteven PO, Werner T, Dees EC, Bergsland E, Agarwal N, Kleha J, Durant M, Adams L, Smith DA, Lampkin TA, Morris SR, Kurzrock R. Resubmission: First-in-human Phase I Study of GSK2126458, an Oral Pan-Class I Phosphatidylinositol-3-kinase inhibitor, in Patients with Advanced Solid Tumor Malignancies. Clin. Cancer Res.. 2016;22(8):1932-1939
Medical condition
Solid Tumours
Product
omipalisib
Collaborators
Not applicable
Study date(s)
August 2009 to March 2015
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
Status
Study Complete
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98109
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75246
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84112-5550
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2012-12-12
Actual study completion date
2015-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 112826 can be found on the GSK Clinical Study Register.
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