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

NCT00493818 | Terminated Phase 1

• 1 other identifier: AKT106757
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer

Keywords

GSK690693,; Solid Tumors,; Lymphoma,; AKT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Blood pressure and heart rate every 8 hours.

  every 8 hours.

• 12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs

  4, 8, 10, 12, 14, 24hrs

• Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.

  draws before, during, and after the infusion

• Urinalysis samples while the patient is hospitalized

  while the patient is hospitalized

Interventions

GSK690693 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Durham, North Carolina, 27710, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Neoplasms; Lymphoma

Interventions

GSK690693

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)