Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00493818
• Other study ID #: AKT106757
• Status: Terminated
• Phase: Phase 1
• First received: June 27, 2007
• Last updated: January 16, 2017
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• GSK690693

Locations

Country	Name	City	State
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.		given weekly or twice weekly over 1 - 4 hours
Secondary	Blood pressure and heart rate every 8 hours.		every 8 hours.
Secondary	12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs		4, 8, 10, 12, 14, 24hrs
Secondary	Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.		draws before, during, and after the infusion
Secondary	Urinalysis samples while the patient is hospitalized		while the patient is hospitalized

External Links

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