Clinical trial · Interventional
Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693
An Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the AKT Inhibitor GSK690693 Given on Various Schedules in Subjects With Solid Tumors or Lymphoma
NCT00493818CI-TRIAL-00025518terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSK690693 | Drug | Pan-AKT Kinase Inhibitor GSK690693 | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.
- timeFrame
- given weekly or twice weekly over 1 - 4 hours
Secondary outcomes (4)
- measure
- Blood pressure and heart rate every 8 hours.
- timeFrame
- every 8 hours.
- measure
- 12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs
- timeFrame
- 4, 8, 10, 12, 14, 24hrs
- measure
- Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.
- timeFrame
- draws before, during, and after the infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy * Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. Exclusion Criteria: * Prior anti-cancer therapy within the prior 28 days. * History of diabetes. * Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months. * Use of theophylline and warfarin within 14 days prior to the first dose of study drug. * Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.) * Participation in an investigational study within the prior 28 days. * Pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.