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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell, Cancer

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Trial Information

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

Inclusion Criteria


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:

- 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.

Exclusion criteria:

- 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).

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part A: excretion of radioactivity

Outcome Time Frame:

over 168 hrs

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

VEG10004

NCT ID:

NCT00478725

Start Date:

July 2007

Completion Date:

July 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Cancer
  • Metastatic Cancer
  • Advanced Cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteGermantown, Tennessee  38138