Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 27, 2007

Last Updated Date

February 5, 2009

Start Date ^†

August 2007

Current Primary Outcome Measures ^†

Plasma levels for GSK461364 will be taken at: Schedule 1: Day 1, 8, 15, & 22 for Cycle 1 and Day 1, 8 & 15 for subsequent cycles. Schedule 2: Day 1, 2, 8, 9, 15, & 16 for all cycles. Schedule 3: Day 1 to 5 for all cycles. [ Time Frame: 16 Days ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536835 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Safety will be evaluated by: - Physical exam at screen & then D1 for each cycle - 12 lead ECG & telemetry at screen & Wk 1 to 3 for Schedule 1 & 2, & Wk 1 & 2 (ECG only) for Schedule 3. - Lab tests & AE monitoring throughout the study. [ Time Frame: 16 Days ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma

Official Title ^†

A Phase I Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of [GSK461364], a Polo-Like Kinase 1 (PLK1) Inhibitor, in Adult Subjects With Advanced Solid Tumor or Non-Hodgkins Lymphoma

Brief Summary

This is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with solid tumors and Non-Hodgkins lymphoma.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^†

Advanced Solid Tumor
Non-Hodgkin's Lymphoma

Intervention ^†

Drug: GSK461364

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Confirmed diagnosis of advanced solid tumor or Non-Hodgkins Lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory to standard therapies
At least 18 years of age
Female who are of non-childbearing potential or who have a negative pregnancy test who uses approved contraception
Male with a female partner of childbearing potential must have had a vasectomy or both are using approved contraception
Lab values that are within range as described in the protocol
Paraffin-embedded archival tumor tissue available for testing
Signed written informed consent

Exclusion Criteria:

Undergone major surgery or received anti-cancer therapy
History of hemolytic anemia
Clinical lab tests that are out of range as described in the protocol
Females who are pregnant or lactating
Significant heart problems
Serious or unstable pre-existing medical or psychiatric condition
Are not able to comply with the study protocol
Use of prohibited medications
Have low blood pressure
Evidence of symptomatic or untreated central nervous system involvement and require corticosteroids or anti-epileptic meds

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: US GSK Clinical Trials Call Center

877-379-3718

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536835

Responsible Party

Study Director, GSK

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.