EUCTR2009-010551-26-HU进行中（未招募）不适用
A Phase I/II Multi-centre Study of AZD8931 in Combination with WeeklyPaclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacyin Patients with Advanced Solid Tumours and in a Selected Population withLow HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer(THYME) - THYME
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 192
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
- 性别
- All
入选标准
- •All patients
- •1. Provision of signed, written informed consent
- •2. Age 18 years and older
- •3. Radiation therapy must be terminated at least 2 weeks prior to enrolment. Patients
- •must have recovered from the toxic effects of prior therapy
- •4. Suitable for paclitaxel therapy
- •5. Life expectancy of more than 12 weeks
- •6. Not previously randomised to treatment in this study
- •7. Females of non-childbearing status defined as one of the following criteria at
- •screening:- negative pregnancy test in women of childbearing potential- or women
- •who are permanently or surgically sterilised (hysterectomy and/or bilateral
- •oopherectomy and/or bilateral salpingectomy) - or postmenopausal (over 50 years
- •old and amenorrheic for 12 months following cessation of all exogenous hormonal
- •treatments, or over 57 years old)
- •8. Not pregnant or breastfeeding if female and of child-bearing potential
- •9. Female patients of child-bearing potential willing to use an acceptable highly
- •effective method of contraception during the study and for 3 months after the last
- •dose of IP. It is recommended that women should have been stable on their chosen
- •method of contraception for at least 3 months before entering the study.
- •Recommended methods of contraception are listed in Appendix J
- •10. No receipt of investigational drug within the 14 days or 5 half-lives, whichever is
- •longer, of the first dose of randomised therapy (AZD8931 or matching placebo) or
- •participated in a previous clinical study during the last 30 days prior to study entry
- •Phase I only
- •40. Male or female with histologically or cytologically confirmed solid, malignant
- •tumour which is refractory to standard therapies, or for which no standard therapies
- •exist. Inclusion is irrespective of stage of disease or extent of prior therapy
- •41. World Health Organisation (WHO) performance status 0 to 2
- •42. No evidence of ‘dry eye’: persistent symptoms of ocular surface irritation,
- •Schirmer’s test without anaesthesia of less than 5 mm in 5 minutes and tear breakup
- •time [TBUT] test of less than 10 seconds (if one of these is satisfactory, the
- •patient may be included – both of these parameters should be normal if the patient
- •is receiving anti-cholinergic medication. Eye conditions that are stable and of long
- •standing, such as scars from trauma, pinguecula, atrophic pterygia etc, should not be
- •considered as reasons to exclude the patient
- •43. Not wearing contact lens (patients should discontinue wearing contact lens from at
- •least 1 week prior to entering the study to 1 week following discontinuation of
- •44. No recent acute changes in patient’s vision, or ongoing symptoms of ocular pain,
- •discomfort or irritation
- •45. No history of collagen vascular, chronic inflammatory or degenerative disease with eye involvement (eg, rheumatoid, Sjögren syndrome, systemic lupus erythematosus [SLE]) or of ocular surface disease (including Steven-Johnson syndrome, ocular cicatricial pemphigoid or chemical burns, herpes simplex or herpes zoster virus eye disease
- •46. No history of corneal surgery, including laser refractive surgery, within the past 3
- •47. Random blood glucose at screening =11.1 mmol/L, or random blood glucose
- •between 7 and 11 mmol/L AND fasting blood glucose =7 mmol/L
- •48. No uncontrolled diabetes mellitus (glycosylated haemoglobin [HbA1c] =9%)
- •Phase II only
- •49. Female patients with histologic or cytologic diagnosis of breast cancer with
- •evidence of unresectable and/or locally recurrent and/ or metastatic disease.
- •Lesions should n
排除标准
- •All the points included in this section are restrictions
- •All patients
- •1. Female patients of child bearing potential must use an acceptable highly effective
- •method of contraception during the study, and for 3 months after the last dose of IP.
- •Recommended methods of contraception are listed in Appendix J
- •2. Patients should use sunglasses and sun cream with UVA and UVB protection
- •SPF>15 if exposed to sunlight and avoid use of sun tanning booths during the study
- •and for 3 months after the last dose of IP
- •3. Patients who are blood donors should not donate blood during the trial and for 3
- •months following their last dose of IP
- •4. All patients must avoid concomitant use of medications, herbal supplements and/or
- •ingestion of foods that significantly modulate CYP3A4 and/or CYP2D6 activity or
- •which are significantly metabolised by CYP3A4 and/or CYP2D6. Such drugs must
- •have been discontinued for an appropriate period before they enter screening and
- •for a period of 2 weeks after the last dose of AZD8931. Guidance on medications
- •to avoid and on washout periods is given in Appendix D
- •5. Refer to the Summary of Product Characteristics (SPC) for restrictions specific to
- •Phase I only
- •6. No food is allowed from 2 hours before to 2 hours after taking IP
- •7. Male patients will be required to use reliable methods of contraception (condom)
- •during any sexual contact with a female of childbearing potential for the duration of
- •the study and until 12 weeks after the last dose of AZD8931 (even if he has
- •undergone successful vasectomy)
- •8. Male patients will be advised to abstain from sperm donation from first dose until
- •12 weeks following receipt of the last dose of AZD8931
- •9. Refrain from driving for 4 hours following ophthalmic examination if pupillary
- •dilatation performed
- •10. Patients should refrain from wearing contact lenses from at least 1week prior to
- •starting AZD8931 to 1 week after discontinuation of AZD8931
- •Phase II only
- •11. Patients should refrain from wearing contact lenses in excess of the recommended
- •daily duration during participation in the study
- •12. Patients should not receive any endocrine treatment whilst receiving IP
研究者
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