Last updated: 11/04/2018 10:15:54
Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects with Non-Hodgkins Lymphoma
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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.
Timeframe: 16 Days
Secondary outcomes:
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.
Timeframe: 16 Days
Interventions:
Drug: GSK461364
Enrollment:
41
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
David Olmos, Douglas Baker, Rohini Sharma, Andre T. Brunetto, Timothy A. Yap, Anne B. Taegtmeyer, Jorge Barriuso, Hanine Medani, Yan Y. Degenhardt, Alicia J. Allred, Deborah A. Smith, Sharon C. Murray, Thomas A. Lampkin, Mohammed M. Dar, Richard Wilson. Phase I Study of GSK461364, a Specific and Competitive Polo-like Kinase 1 Inhibitor, in Patients with Advanced Solid Malignancies. [Clinical Cancer Research]. 2011;17(10):1-11.
David Olmos, Douglas Baker, Rohini Sharma, Andre T. Brunetto, Timothy A. Yap, Anne B. Taegtmeyer, Jorge Barriuso, Hanine Medani, Yan Y. Degenhardt, Alicia J. Allred, Deborah A. Smith, Sharon C. Murray, Thomas A. Lampkin, Mohammed M. Dar, Richard Wilson. Phase I Study of GSK461364, a Specific and Competitive Polo-like Kinase 1 Inhibitor, in Patients with Advanced Solid Malignancies. Clinical Cancer Research.2011;17(10):3420-30
David Olmos, Douglas Baker, Rohini Sharma, Andre T. Brunetto, Timothy A. Yap, Anne B. Taegtmeyer, Jorge Barriuso, Hanine Medani, Yan Y. Degenhardt, Alicia J. Allred, Deborah A. Smith, Sharon C. Murray, Thomas A. Lampkin, Mohammed M. Dar, Richard Wilson.Phase I Study of GSK461364, a Specific and Competitive Polo-like Kinase 1 Inhibitor, in Patients with Advanced Solid Malignancies.Clinical Cancer Research.2011;17(10):3420-30
Medical condition
Lymphoma, Non-Hodgkin
Product
GSK461364
Collaborators
Not applicable
Study date(s)
August 2007 to September 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Undergone major surgery or received anti-cancer therapy
- History of hemolytic anemia
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Status
Study Complete
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-29-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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