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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-16

Study Completion Date

2009-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stage A

Stage A will identify maximum tolerated doses for either Schedule 1 - GSK461364 given once weekly on Day 1, 8 and 15 every 28 days; Schedule 2 - GSK 461364 given twice weekly Days 1, 2, 8, 9, 15 and 16; Schedule 3 Daily on Day 1 to Day 15 every 21 days.

Group Type EXPERIMENTAL

GSK461364

Intervention Type DRUG

GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.

Stage B

Evaluate safety, PK, pharmacodynamic (PD) \& tumor response in expanded cohorts at the MTD for at least one schedule from Stage A.

Group Type EXPERIMENTAL

GSK461364

Intervention Type DRUG

GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.

Interventions

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GSK461364

GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Sutton, Surrey, United Kingdom

Site Status

GSK Investigational Site

Belfast, Northern Ireland, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Olmos D, Barker D, Sharma R, Brunetto AT, Yap TA, Taegtmeyer AB, Barriuso J, Medani H, Degenhardt YY, Allred AJ, Smith DA, Murray SC, Lampkin TA, Dar MM, Wilson R, de Bono JS, Blagden SP. Phase I study of GSK461364, a specific and competitive Polo-like kinase 1 inhibitor, in patients with advanced solid malignancies. Clin Cancer Res. 2011 May 15;17(10):3420-30. doi: 10.1158/1078-0432.CCR-10-2946. Epub 2011 Apr 1.

Reference Type BACKGROUND

PMID: 21459796 (View on PubMed)

Study Documents

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