Last updated: 11/04/2018 13:08:10

Part A: Radiolabel study with GW786034 Part B: Single dose of GW786034

GSK study ID
VEG10004
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Two-Part Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Pazopanib (GW786034) and the Absorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of Pazopanib in Subjects with Solid Tumor Malignancies
Trial description: To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Part A: excretion of radioactivity

Timeframe: 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)

Timeframe: over 48 hrs

Secondary outcomes:

Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2

Timeframe: over 168 hrs.

Part B: Safety parameters

Timeframe: 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.

Timeframe: 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.

Timeframe: on Day 15 of Cycle 1.

Blood:plasma ratio of total drug-related material (radioactivity).

Timeframe: 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.

Timeframe: on Day 15 of Cycle 1.

Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments.

Timeframe: on Day 15 of Cycle 1.

Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib

Timeframe: on Day 15 of Cycle 1.

Interventions:
Drug: GW786034, oral
Drug: GW786034, IV
Drug: GW786034, radiolabeled oral
Enrollment:
10
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Deng Y, Sychterz C, Suttle B, et al. Metabolism and Disposition of Oral Pazopanib in Patients with Advanced Cancer. Xenobiotica. 2013;43(5):443-53.
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
July 2007 to July 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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.
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to beginning study treatment. Screening with CNS imaging studies (CT scan or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases.
  • Clinically significant gastrointestinal (GI) abnormalities including, but not limited to: malabsorption syndrome, history of resection of the stomach or small bowel, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other conditions that increase the risk for perforation, history of abdominal fistula, GI perforation or intra-abdominal abscess within 4 weeks prior to beginning study treatment.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Recruiting

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
2008-01-07

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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Additional information
Results for study VEG10004 can be found on the GSK Clinical Study Register.
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