Last updated: 11/04/2018 13:34:08
Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase II, Open-Label Study of Pazopanib (GW786034) in Patients with Relapsed or Refractory Multiple Myeloma
Trial description: The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW786034
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Prince HM, Honemann D, Spencer A, et al. Vascular endothelial growth factor inhibition is not an effective therapeutic strategy for relapsed or refractory multiple myeloma: a phase 2 study of pazopanib (GW786034). Blood. 2009;113(19):4819-4820.
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
January 2005 to December 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
21+ years
Accepts healthy volunteers
No
- Must have diagnosis of relapsed or refractory multiple.
- bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet count greater than or equal to 75,000/mm3.
- Failed more than 3 prior lines of therapy including stem cell transplant.
- Females who are pregnant or nursing.
Inclusion and exclusion criteria
Inclusion criteria:
- Must have diagnosis of relapsed or refractory multiple.
- bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet count greater than or equal to 75,000/mm3.
- renal function (calculated creatinine clearance >50 mL.min, albumin less than or equal to 500 mg).
Exclusion criteria:
- Failed more than 3 prior lines of therapy including stem cell transplant.
- Females who are pregnant or nursing.
- Unstable blood pressure.
- Significant heart conditions or history of thrombosis.
- Any unstable, pre-existing major medical condition or history of other cancers.
- Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.
Trial location(s)
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98109
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
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
2005-15-12
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
Additional information
Not applicable
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