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

This study is currently recruiting participants.

Verified by GlaxoSmithKline, February 2009

First Received: September 27, 2007 Last Updated: February 5, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00536835

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Tumor Non-Hodgkin's Lymphoma	Drug: GSK461364	Phase I

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by GlaxoSmithKline:

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 ]

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 ]

Estimated Enrollment:	50
Study Start Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536835

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

United Kingdom
GSK Investigational Site	Recruiting
Belfast, Northern Ireland, United Kingdom, BT9 7AB
GSK Investigational Site	Recruiting
London, United Kingdom, W12 0NN
United Kingdom, Surrey
GSK Investigational Site	Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	PLK107427
Study First Received:	September 27, 2007
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00536835 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:

Advanced Solid Tumor
Non-Hodgkins Lymphoma
Cancer

GSK461364
First time in human
PLK1 inhibitor

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 06, 2009