EUCTR2013-004851-19-GB进行中（未招募）1 期
A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma. - Pazopanib-Surgically Unresectable or Metastatic Chondrosarcoma_V1.0
ACORN Research, LLC0 个研究点目标入组 47 人开始时间: 2015年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subjects 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.
- •2. Age = 18 years
- •3. Histologically confirmed diagnosis of conventional chondrosarcoma of any grade
- •4. Surgically unresectable or metastatic disease
- •5. Any number of prior treatment regimens, including treatment naïve subjects
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Appendix 2)
- •7. Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1
- •8. Adequate organ system function as defined in Table 5 (in protocol) determined within 14 days prior to the first dose of study treatment.
- •9. A female 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
- •Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for = 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L).
- •Subjects using HRT must have experienced total cessation of menses for = 1 year and be greater than 45 years of age, OR, have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT.
- •Childbearing potential, including any female who has had a negative serum pregnancy test within 7 days prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
- •? Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product [Hatcher, 2004]
- •? Oral contraceptive, either combined or progestogen alone [Hatcher, 2004]
- •? Injectable progestogen [Hatcher, 2004]
- •? Implants of levonorgestrel [Hatcher, 2004]
- •? Estrogenic vaginal ring [Hatcher, 2004]
- •? Percutaneous contraceptive patches [Hatcher, 2004]
- •? Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year [Hatcher, 2004].
- •? Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject [Hatcher, 2004].
- •? Double barrier method: condom and an occlusive
排除标准
- •1. Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes
- •2. Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- •3. 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 first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
- •4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •? Active peptic ulcer disease
- •? Known intraluminal metastatic lesion(s) with risk of bleeding
- •? Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation
- •? History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
- •5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- •? Malabsorption syndrome
- •? Major resection of the stomach or small bowel.
- •6. Presence of uncontrolled infection.
- •7. Corrected QT interval (QTc) > 480 msecs using Bazett’s formula
- •8. History of any one or more of the following cardiovascular conditions within the past 6 months:
- •? Cardiac angioplasty or stenting
- •? Myocardial infarction
- •? Unstable angina
- •? Coronary artery bypass graft surgery
- •? Symptomatic peripheral vascular disease
- •? Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) [Appendix 5]
- •9. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of = 140 mmHg or diastolic blood pressure (DBP) of = 90mmHg].
- •Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be < 140/90 mmHg in order for a subject to be eligible for the study (see Section 7.1 for details on BP control and re-assessment prior to study enrollment).
- •10. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or 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.
- •11. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. Major surgery is defined by the use of
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