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To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Absorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of GW786034 |
|
| Part B | Experimental | characterize the pharmacokinetics of a single IV dose of GW786034 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW786034, oral | Drug | oral, 800 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: excretion of radioactivity | over 168 hrs | |
| Part B: Plasma pazopanib, clearance (CL) and AUC(0-t), AUC(0-8),Cmax and half-life (t1/2) pazopanib and pazopanib metabolites (GSK 1268992, GSK1268997, GSK1071306 and GW700201) | over 48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2 | over 168 hrs. | |
| Part B: Safety parameters | over 48 hrs. | |
| Blood and plasma total radioactivity AUC(0-t), AUC(0-∞), Cmax and t1/2 following oral administration of 400 mg of [14C]-pazopanib containing approximately 70 µCi of radioactivity. |
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Inclusion criteria:
Subject must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
Has histologically or cytologically confirmed advanced solid tumor malignancy.
For Part A: Males, age: 30 years or greater.
For Part B: Males or Females, age: 18 years or greater.
For Part A or B, males that meet the following criteria.
A male subject with a female partner of childbearing potential is eligible to enter and participate in this study if he:
For Part B, females that meet the following criteria:
A female subject is eligible to enter and participate in this study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
Childbearing potential and has a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
Note: Oral contraceptives are not considered reliable due to potential drug-drug interaction.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Body weight >/ 50 kg.
Adequate organ systems function as defined in Table 1.
Ability to swallow and retain oral medication.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23548165 | Background | Deng Y, Sychterz C, Suttle AB, Dar MM, Bershas D, Negash K, Qian Y, Chen EP, Gorycki PD, Ho MY. Bioavailability, metabolism and disposition of oral pazopanib in patients with advanced cancer. Xenobiotica. 2013 May;43(5):443-53. doi: 10.3109/00498254.2012.734642. Epub 2012 Nov 16. |
| Label | URL |
|---|---|
| Results for study VEG10004 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
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| GW786034, IV | Drug | IV, 5 mg |
|
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| GW786034, radiolabeled oral | Drug | oral, 400 mg radiolabeled |
|
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| on Day 15 of Cycle 1. |
| Samples (for use in a separate study) to characterize and quantify metabolites of pazopanib in plasma, urine and feces. | on Day 15 of Cycle 1. |
| Blood:plasma ratio of total drug-related material (radioactivity). | on Day 15 of Cycle 1. |
| Plasma pazopanib AUC(0-t), AUC(0-∞), Cmax, tmax following oral administration of 400 mg of [14C]-pazopanib containing 70 µCi of radioactivity. | on Day 15 of Cycle 1. |
| Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments. | on Day 15 of Cycle 1. |
| Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib | on Day 15 of Cycle 1. |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |