EUCTR2008-006344-19-ES进行中（未招募）1 期
Ensayo fase II, doble ciego, aleatorizado para evaluar la eficacia de AZD6244 (hidrógeno-sulfato) combinado con dacarbazina, en comparación con dacarbazina sola, como tratamiento de primera línea en pacientes con melanoma cutáneo o melanoma primario desconocido avanzado y mutación positiva de BRAFA Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •1. Provision of signed, written and dated informed consent prior to any study specific procedures
- •2. Male or female, aged 18 years or older
- •3. Histological or cytological confirmation of advanced cutaneous or unknown primary melanoma
- •4. WHO performance status 0-1
- •5. At least one lesion, not previously irradiated, that can be accurately measured at
- •baseline as higher or equal to 10 mm in the longest diameter (LD; except lymph nodes which must
- •have a short axis higher or equal to 15 mm) with CT or MRI, and which is suitable for accurate
- •repeated measurements
- •6. Tumour sample confirmed as BRAF mutation positive (Note: sample must be available upon enrolment to ship to the AstraZeneca appointed central laboratory, or mutation status confirmed locally at an AstraZeneca approved local laboratory
- •using agreed methodology
- •7. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Post-menopausal status is defined as:
- •- natural menopause with menses >1 year ago
- •- radiation-induced oophorectomy with last menses >1 year ago
- •- chemotherapy-induced menopause with 1 year interval since last menses
- •- serum FSH, LH and plasma oestradiol levels in the postmenopausal range for
- •the institution
- •- bilateral oophorectomy or hysterectomy
- •8. Serum creatinine clearance >50 ml/min, by either Cockcroft-Gault formula or 24-hour urine collection analysis
- •9. Patients should be able to swallow AZD6244/placebo capsules.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
- •2. Previous randomization of treatment in the present study
- •3. Having received an investigational drug within the 30 days prior to entry, or have
- •not recovered from side effects of an investigational drug
- •4. Diagnosis of uveal or mucosal melanoma
- •5. Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
- •6. Any prior cytotoxic chemotherapy or biochemotherapy for advanced melanoma
- •- patients who previously received adjuvant biochemotherapy will be eligible,
- •unless their treatment included temozolomide or dacarbazine
- •7. Any other investigational non-chemotherapeutic therapy for advanced melanoma,
- •with the exception of prior monotherapy with interleukin-2, cytokines (eg,
- •alfa-interferon or GM-CSF) or vaccine, which are permitted
- •- use of anti-CTLA4 monoclonal antibodies will be allowed in adjuvant settings
- •8. Any non-systemic therapy (except focal palliative radiotherapy) for advanced
- •melanoma within 30 days of starting study treatment
- •9. Any unresolved toxicity above CTCAE grade 2 from previous anti-cancer therapy,
- •apart from alopecia
- •10. Brain metastases or spinal cord compression unless treated and stable off treatment
- •(eg, steroids) for at least 3 months
- •11. Laboratory values as listed below (from laboratory results at Visit 1):
- •- ANC <1.5x109/L (1,500 per mm3)
- •- Platelets <100x109/L (100,000 per mm3)
- •- Haemoglobin lower or equal to 9.0 g/dL
- •- Serum bilirubin >1.5xULN
- •- AST or ALT >2.5xULN
- •12. LDH higher or equal to 2xULN (from the Visit 1 laboratory result)
- •13. Cardiac conditions as follows:
- •- Uncontrolled hypertension (BP higher or equal to 150/95 despite optimal therapy)
- •- Heart failure NYHA Class II or above
- •- Prior or current cardiomyopathy
- •- Baseline LVEF lower or equal to 50%
- •- Atrial fibrillation with heart rate >100 bpm
- •- Unstable ischaemic heart disease (myocardial infarction within 6 months prior
- •to starting treatment, or angina requiring use of nitrates more than once weekly)
- •14. Major surgery within 4 weeks prior to starting study treatment
- •15. Hypersensitivity to AZD6244, or dacarbazine or any excipient of these agents
- •16. Patients with a history of another primary malignancy within 5 years prior to
- •starting study treatment, except adequately treated basal or squamous cell
- •carcinoma of the skin, or carcinoma of the cervix in situ and the disease under study
- •17. Any evidence of severe or uncontrolled systemic disease, active infection, active
- •bleeding diathesis or renal transplant, including any patient known to have
- •hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •18. Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatorybowel disease), or significant bowel resection that would preclude adequate absorption
- •19. Female patients who are breast-feeding or patients of reproductive potential who are not employing an effective method of birth control
- •20. Clinical judgement by the investigator that the patient should not participate in the study.
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