EUCTR2012-002042-21-FR进行中（未招募）1 期
AN OPEN-LABEL, PHASE I/II, DOSE-ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF GDC-0032 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS AND IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HORMONE RECEPTOR-POSITIVE BREAST CANCER
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
- 392
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
- •Phase I: Histologically documented, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit
- •Phase II: Post-menopausal female patients with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer
- •Evaluable or measurable disease per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening
- •Life expectancy of >= 12 weeks
- •Adequate haematologic and organ function within 14 days prior to initiation of study treatment
- •Documented willingness to use an effective means of contraception for both men and women while participating in the study
- •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 212
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring treatment)
- •Grade >=2 peripheral neuropathy
- •Active congestive heart failure or ventricular arrhythmia requiring medication
- •Patients requiring any daily supplemental oxygen
- •Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Treatment with chemotherapy <= 3 weeks before study treatment
- •Treatment with investigational drug <= 4 weeks before study treatment
- •Treatment with biologic therapy <= 3 weeks before study treatment
- •Treatment with kinase inhibitors <= 2 weeks before study treatment
- •Radiation therapy (other than radiation to bony metastases) as cancer therapy <= 4 weeks before study treatment
- •Palliative radiation therapy to bony metastases <= 2 weeks before study treatment
- •Major surgery <= 4 weeks before study treatment
- •Oral endocrine therapy <= 2 weeks prior initiation of study treatment.
- •For patients in Phase II and in Stage 2, Cohorts, J, K, L and M: prior treatment with fulvestrant
- •For patients in Stage 2, Cohorts, J, K, L, M, N and P and patients in phase II: Prior treatment with > 1 cytotoxic chemotherapy regimen in the metastatic setting. (Prior treatment with everolimus is permitted and is not considered a cytotoxic chemotherapy.)
- •Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications
研究者
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