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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00536835
First received: September 27, 2007
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  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
Lymphoma, Non-Hodgkin
Non-Hodgkin's Lymphoma
 Drug: GSK461364
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

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 ]

Enrollment: 41
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: 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.
Other Name: GSK461364
Experimental: Stage B
Evaluate safety, PK, pharmacodynamic (PD) & tumor response in expanded cohorts at the MTD for at least one schedule from Stage A.
 Drug: 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.
Other Name: GSK461364

  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

Locations
United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
GSK Investigational Site
Belfast, Northern Ireland, United Kingdom, BT9 7AB
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00536835     History of Changes
Other Study ID Numbers: PLK107427
Study First Received: September 27, 2007
Last Updated: May 31, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Non-Hodgkins Lymphoma
Cancer
First time in human
 PLK1 inhibitor
Advanced Solid Tumor
GSK461364

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013