EUCTR2009-010551-26-FR进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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. Suitable for paclitaxel therapy
- •4. Life expectancy of more than 12 weeks
- •5. Not previously enrolled/randomised to treatment in this study
- •6. Females must be of non childbearing status defined as one of the following criteria at screening:
- •-negative pregnancy test in women of childbearing potential
- •-women who are permanently or surgically sterilised (hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy)
- •-postmenopausal (over 50 years old and amenorrheic for 12 months following cessation of all exogenous hormonal treatments, or over 57 years old)
- •7. Females must not be breastfeeding
- •8. Female patients of child bearing potential must use an acceptable highly effective method of contraception plus condoms plus spermicide during the study and for 30 days after the last dose of study drug. 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
- •9. Patients must not have received an investigational drug within 30 days or 5 half lives, whichever is longer, of the first dose of randomised therapy (AZD8931 or matching placebo)
- •10. A haemoglobin =9 g/dL (5.59 mmol/L). [Note: any blood transfusion must be >14 days prior to the determination of a haemoglobin =9 g/dL (5.59 mmol/L)]
- •Phase II only
- •37. Female patients with histologic or cytologic diagnosis of breast cancer with evidence of locally advanced (not amenable to surgery) or metastatic disease. Lesions should not be amenable to surgery or radiation of curative intent
- •38. Patients must not have received previous taxane therapy in an adjuvant setting, within 12 months prior to the start of AZD8931/matching placebo
- •39. Patients must not have received taxane therapy for treatment of locally advanced (not amenable to surgery) or metastatic breast cancer
- •40. Patients must not have received more than one cytotoxic chemotherapy regimen for the treatment of locally advanced (not amenable to surgery) or metastatic breast cancer. (Previous endocrine therapy for the treatment of the locally advanced, or metastatic breast cancer with endocrine therapy is permitted)
- •41. Patients must be deemed ineligible for trastuzumab or lapatinib treatment (ie, are not IHC3+ or IHC2+/FISH or CISH +ve for HER2 by an approved assessment modality)
- •-Tumour tissue sample provision for central analysis is a mandatory part of the screening procedures and must be available. The sample can be taken from archival diagnostic tissue from the original biopsy or a more recent biopsy. Both primary lesion and metastatic sites are acceptable. Notification of patient eligibility will come from the central laboratory informing the site that HER2 expression is within limits for randomisation
- •42. At least one lesion, not previously irradiated, that can be accurately measured at baseline as =10 mm in the longest diameter (except lymph nodes which must have short axis =15 mm) with computed tomography (CT) scan or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements
- •43. WHO performance status 0 to 1
- •44. Patients must not have received previous therapy with an agent that targets ErbB1 and/or ErbB2 (including trastuzumab or lapatinib)
- •45. Patients receiving biphosphonate therapy must have been on their current dose without change for 4 weeks p
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 plus condoms plus spermicide during the study and for 30 days after last dose of AZD8931/matching placebo.
- •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. Male patients (including those that have undergone a successful vasectomy) must use condoms plus spermicide during sexual contact with a female of child-bearing potential who is not using a highly effective method of contraception, for the duration of the study and for 3 months after the last dose of AZD8931
- •7. Male patients will be advised to abstain from sperm donation from first dose until
- •3 months following receipt of the last dose of AZD8931
- •8. Refrain from driving for 4 hours following ophthalmic examination if pupillary
- •dilatation performed
- •9. 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
- •10. Patients who wear contact lenses should discontinue wearing their lenses if they have any mild to moderate eye symptoms (CTCAE grade =2) while receiving treatment with AZD8931 until at least one week after symptoms have resolved. If a patient has a recurrence of eye symptoms or experiences any severe (CTCAE grade =3) ocular events they should discontinue wearing their contact lenses until at least one week after treatment with AZD8931 is permanently discontinued
- •11. Patients should not use any eye drops or ointment for treatment of eye symptoms, unless prescribed by a study doctor, at any time during the study until 1 week after AZD8931 has been permanently discontinued
- •12. Patients should not receive endocrine therapy prior to progression of their disease
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