Last updated: 11/04/2018 04:40:26
Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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:
Blood pressure and heart rate every 8 hours.
Timeframe: every 8 hours.
12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs
Timeframe: 4, 8, 10, 12, 14, 24hrs
Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.
Timeframe: draws before, during, and after the infusion
Urinalysis samples while the patient is hospitalized
Timeframe: while the patient is hospitalized
Interventions:
Drug: GSK690693
Enrollment:
70
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer
Product
GSK690693
Collaborators
Not applicable
Study date(s)
April 2007 to June 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- Prior anti-cancer therapy within the prior 28 days.
- History of diabetes.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Terminated/Withdrawn
Study documents
Clinical study report
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
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2008-08-06
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website