Open-label Study to Investigate the Safety, Tolerability,... | NCT00493818

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

NCT00493818

Sponsor

GlaxoSmithKline

Status

Terminated

Last Update Posted

Jan 18, 2017Estimated

Enrollment

70Estimated

Phase

Phase 1

Conditions

Cancer

Interventions

GSK690693

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 27, 2007

First Submission Date that Met QC Criteria

Jun 27, 2007

First Posted Date

Jun 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Name	Type	Description	Arm Group Labels	Other Names
GSK690693	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Indianapolis	Indiana	46202	United States
GSK Investigational Site

References Module

Citations

Not provided

ID	Term
D009369	Neoplasms
D008223	Lymphoma

ID	Term
D009370	Neoplasms by Histologic Type
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases