Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma
Tracking Information | |||||
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First Received Date ICMJE | November 21, 2005 | ||||
Last Updated Date | November 10, 2011 | ||||
Start Date ICMJE | January 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory multiple myeloma (MM). | ||||
Original Primary Outcome Measures ICMJE |
Evaluate the safety and tolerability of GW786034 in patients with relapsed or refractory MM. | ||||
Change History | Complete list of historical versions of study NCT00256880 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with MM. | ||||
Original Secondary Outcome Measures ICMJE |
Evaluate time-to-tumor progression (TTP), time to response, and duration of response. Characterize the pharmacokinetics of GW786034 in patients with M | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma | ||||
Official Title ICMJE | A Phase II, Open-Label Study of Pazopanib (GW786034) in Patients With Relapsed or Refractory Multiple Myeloma | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: GW786034
Other Name: GW786034 |
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Study Arm (s) | |||||
Publications * | Prince HM, Hönemann D, Spencer A, Rizzieri DA, Stadtmauer EA, Roberts AW, Bahlis N, Tricot G, Bell B, Demarini DJ, Benjamin Suttle A, Baker KL, Pandite LN. 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 May 7;113(19):4819-20. No abstract available. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 100 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 21 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Australia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256880 | ||||
Other Study ID Numbers ICMJE | VEG20006 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | November 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |