Carcinoma, Renal CellPhase 1NCT00478725
Part A: Radiolabel Study With GW786034 Part B: Single Dose of GW786034
A Phase 1 study testing GW786034, oral, GW786034, IV and GW786034, radiolabeled oral in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- GW786034, oral, GW786034, IV and GW786034, radiolabeled oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2007to 1 Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Agrees to use double-barrier contraception (condom with spermicidal jelly, foam, suppository or film, or a condom and his partner uses a diaphragm with spermicide), OR
- Agrees to complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the clinical trial, and for at least 21 days after the last dose of investigational product.
- 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:
- A hysterectomy
- A bilateral oophorectomy (ovariectomy)
- A bilateral tubal ligation
- Is post-menopausal (total cessation of menses for >/ 1 year), OR
- 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:
- An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
- Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the clinical trial, and for at least 21 days after the last dose of investigational product.
- Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
- 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.
Who cannot join
- 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.
- Presence of uncontrolled infection.
- Corrected QT interval (QTc) > 480 msec.
- History of any one or more of the following cardiovascular conditions within the past 6 months: congestive heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina OR symptomatic peripheral vascular disease.
- Has poorly controlled hypertension (systolic blood pressure [SBP] >/ 140 mmHg, or diastolic blood pressure [DBP] >/ 90 mmHg).
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- Note: Initiation or adjustment of anti-hypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on 2 occasions that are separated by a minimum of 24 hours. The mean SBP/DBP values from both BP assessments must be < 140/90 mmHg in order for a subject to be eligible for the study.
- History of cerebrovascular accident or pulmonary embolism within the past 6 months.
- History of untreated deep venous thrombosis (DVT) within the past 6 months.
- Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
- Prior major surgery or trauma within the past 28 days or presence of any wound, fracture or ulcer which is not fully healed.
- Evidence of active bleeding, bleeding diathesis or hemoptysis within 6 weeks prior to study treatment.
- Use of prohibited medications within the timeframes specified in Section 9.2, Prohibited Medications of the protocol.
- Use of an investigational agent, including an investigational anti-cancer agent within 28 days or 5 half-lives, whichever is longer, preceding the first dose of pazopanib.
- Treatment with any cancer therapy (including chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery or tumor embolization) within 14 days prior to the first dose of pazopanib.
- Note: Current treatment with leuprolide is permitted.
- Any ongoing potentially reversible toxicity from prior anti-cancer therapy that is > Grade 1 or any toxicity from prior anti-cancer therapy that is progressing in severity.
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study, including any condition that could interfere with the accurate assessment and recovery of [14C].
- History or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
Nashville, Tennessee, 37203
About this study
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
To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034
- Conditions
- Carcinoma, Renal Cell
- Being tested
- GW786034, oral, GW786034, IV, GW786034, radiolabeled oral
- Keywords
- Metastatic Cancer, Advanced Cancer
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW786034, oralDrug
Also called GW786034, pazopanib
oral, 800 mg
GW786034, IVDrug
Also called GW786034, pazopanib
IV, 5 mg
GW786034, radiolabeled oralDrug
Also called GW786034, pazopanib
oral, 400 mg radiolabeled
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Absorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of GW786034 Receives: Drug: GW786034, oral; Drug: GW786034, radiolabeled oral |
| Part B | Experimental | characterize the pharmacokinetics of a single IV dose of GW786034 Receives: Drug: GW786034, oral; Drug: GW786034, IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: excretion of radioactivity
Measured: 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)
Measured: over 48 hrs
Secondary outcomes (8)
Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2
Measured: over 168 hrs.
Part B: Safety parameters
Measured: 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.
Measured: 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.
Measured: on Day 15 of Cycle 1.
Blood:plasma ratio of total drug-related material (radioactivity).
Measured: 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.
Measured: on Day 15 of Cycle 1.
Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments.
Measured: on Day 15 of Cycle 1.
Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib
Measured: on Day 15 of Cycle 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study start18 Jul 2007
- Primary completion1 Jul 2008
- Study completion1 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478725
- Sponsor's protocol ID
- VEG10004
- Status last verified
- Nov 2017
- First submitted
- 24 May 2007
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23548165
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00478725
- Acronym / sponsor ID
- VEG10004
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Metastatic Cancer, Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2007 (actual)
- Primary completion
- 1 Jul 2008 (actual)
- Study completion
- 1 Jul 2008 (actual)
- First posted
- 25 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: GW786034, oral, Drug: GW786034, radiolabeled oralAbsorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of GW786034 |
| Part B | Experimental | Drug: GW786034, oral, Drug: GW786034, IVcharacterize the pharmacokinetics of a single IV dose of GW786034 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- Presence of uncontrolled infection.
- Corrected QT interval (QTc) > 480 msec.
- History of any one or more of the following cardiovascular conditions within the past 6 months: congestive heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina OR symptomatic peripheral vascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW786034, oralAlso: GW786034, pazopaniboral, 800 mg | Drug | Part A, Part B |
| GW786034, IVAlso: GW786034, pazopanibIV, 5 mg | Drug | Part B |
| GW786034, radiolabeled oralAlso: GW786034, pazopaniboral, 400 mg radiolabeled | Drug | Part A |
Primary outcome
Part A: excretion of radioactivity
Time frame: 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)
Time frame: over 48 hrs
8 secondary outcomes
Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2
Time frame: over 168 hrs.
Part B: Safety parameters
Time frame: 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.
Time frame: 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.
Time frame: on Day 15 of Cycle 1.
Blood:plasma ratio of total drug-related material (radioactivity).
Time frame: 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.
Time frame: on Day 15 of Cycle 1.
Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments.
Time frame: on Day 15 of Cycle 1.
Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib
Time frame: on Day 15 of Cycle 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 23548165Deng 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.
- Results for study VEG10004 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW786034, oral, GW786034, IV and GW786034, radiolabeled oral in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: excretion of radioactivity (time frame: over 168 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.