Clinical trial · Interventional
Dose-Escalation Study of GSK2126458
A Phase I Open-Label, Dose-Escalation Study of the Phosphoinositide 3-Kinase Inhibitor GSK2126458 in Subjects With Solid Tumors or Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSK2126458 | Drug | Omipalisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GSK2126458
- description
- GSK2126458 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.
- interventionNames
- Drug: GSK2126458
Primary outcomes (1)
- measure
- 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 (1)
- measure
- Metabolic profile in plasma at the maximum tolerated dose
- timeFrame
- Subjects continue on study until disease progression or consent withdrawal
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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