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

Primary Purpose

Lymphoma, Non-Hodgkin

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

GSK461364

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Non-Hodgkins Lymphoma, Cancer, First time in human, PLK1 inhibitor, Advanced Solid Tumor, GSK461364

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Stage A

Stage B

Arm Description

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.

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

Outcomes

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.

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.

Full Information

NCT ID

NCT00536835

First Posted

September 27, 2007

Last Updated

June 23, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00536835

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

August 16, 2007 (Actual)

Primary Completion Date

September 29, 2009 (Actual)

Study Completion Date

September 29, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin

Keywords

Non-Hodgkins Lymphoma, Cancer, First time in human, PLK1 inhibitor, Advanced Solid Tumor, GSK461364

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stage A

Arm Type

Experimental

Arm Description

Arm Title

Stage B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GSK461364

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

16 Days

Secondary Outcome Measure Information:

Title

Time Frame

16 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Belfast, Northern Ireland

ZIP/Postal Code

BT9 7AB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

W12 0NN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

21459796

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

PLK107427

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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