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Part A: Radiolabel Study With GW786034 Part B: Single Dose of GW786034

2017년 11월 13일 업데이트: GlaxoSmithKline

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

연구 개요

연구 유형

중재적

등록 (실제)

10

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Minnesota
      • Minneapolis, Minnesota, 미국, 55404
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • GSK Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part A
Absorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of GW786034
oral, 800 mg
다른 이름들:
  • GW786034
  • 파조파닙
oral, 400 mg radiolabeled
다른 이름들:
  • GW786034
  • 파조파닙
실험적: Part B
characterize the pharmacokinetics of a single IV dose of GW786034
oral, 800 mg
다른 이름들:
  • GW786034
  • 파조파닙
IV, 5 mg
다른 이름들:
  • GW786034
  • 파조파닙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Part A: excretion of radioactivity
기간: over 168 hrs
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)
기간: over 48 hrs
over 48 hrs

2차 결과 측정

결과 측정
기간
Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2
기간: over 168 hrs.
over 168 hrs.
Part B: Safety parameters
기간: over 48 hrs.
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.
기간: on Day 15 of Cycle 1.
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.
기간: on Day 15 of Cycle 1.
on Day 15 of Cycle 1.
Blood:plasma ratio of total drug-related material (radioactivity).
기간: on Day 15 of Cycle 1.
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.
기간: on Day 15 of Cycle 1.
on Day 15 of Cycle 1.
Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments.
기간: on Day 15 of Cycle 1.
on Day 15 of Cycle 1.
Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib
기간: on Day 15 of Cycle 1.
on Day 15 of Cycle 1.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2007년 7월 18일

기본 완료 (실제)

2008년 7월 1일

연구 완료 (실제)

2008년 7월 1일

연구 등록 날짜

최초 제출

2007년 5월 24일

QC 기준을 충족하는 최초 제출

2007년 5월 24일

처음 게시됨 (추정)

2007년 5월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 11월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 11월 13일

마지막으로 확인됨

2017년 11월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다