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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumor, Lymphoma, Non-Hodgkin, Non-Hodgkin's Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

16 Days

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

European Union: European Medicines Agency

Study ID:

PLK107427

NCT ID:

NCT00536835

Start Date:

August 2007

Completion Date:

September 2009

Related Keywords:

  • Advanced Solid Tumor
  • Lymphoma, Non-Hodgkin
  • Non-Hodgkin's Lymphoma
  • Non-Hodgkins Lymphoma
  • Cancer
  • First time in human
  • PLK1 inhibitor
  • Advanced Solid Tumor
  • GSK461364
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neoplasms

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