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临床试验/NCT02285179
NCT02285179已完成1 期

Phase I/Prospective Randomized Phase II Trial Of the Safety and Efficacy of Tamoxifen in Combination With GDC-0032 Compared With Tamoxifen alONe.

The Netherlands Cancer Institute14 个研究点 分布在 4 个国家目标入组 189 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
189
试验地点
14
主要终点
Number of patients with MTD toxicity

研究概览

简要总结

This study is designed as a phase 1 dose escalation study followed by a randomised phase II study. The study will be performed in three different centres: Addenbrooke & Cambridge university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron Hospital (Barcelona, Spain).

Three to six patients will be followed for one completed cycle of therapy (28 days) and subsequent enrolment of new cohorts will be based on the safety assessment in that first cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alone.

详细描述

To determine the recommended phase II dose (RPTD) of GDC-0032 in combination with tamoxifen in hormone receptor positive, HER2 negative metastatic breast cancer patients who have progressed after prior endocrine treatment .Description of toxicity profile, severity and frequency of adverse events (observed with the combination of GDC-0032 and tamoxifen To evaluate the safety and tolerability of GDC-0032 in combination with tamoxifen, recording adverse events using CTCAE v. 4.0 criteria To describe the pharmacokinetics of GDC-0032 in combination with tamoxifen To investigate the possibility of major drug-drug interactions (PK) To obtain proof of target inhibition by selected pharmacodynamic measurements To look for preliminary evidence of anti-tumour activity To assess the status of potential biomarkers for drug response like PIK3CA gene mutations, relevant proteins and phospho-proteins in the PI3K pathway, circulating tumour DNA (ct-DNA) To assess germline DNA sequence for pharmacogenetics studies

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

double blinded study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

tamoxifen and GDC-0032

Experimental

20 mg tamoxifen QD and 4 MG GDC-0032 QOD

干预措施: GDC-0032 (Drug)

tamoxifen and GDC-0032

Experimental

20 mg tamoxifen QD and 4 MG GDC-0032 QOD

干预措施: Tamoxifen (Drug)

tamoxifen and placebo

Placebo Comparator

20 mg tamoxifen QD and placebo QOD

干预措施: Tamoxifen (Drug)

结局指标

主要结局

Number of patients with MTD toxicity

时间窗: 4 weeks

MTD toxicity will be assessed in the first 28 days of treatment

次要结局

  • Safety Number of patients with adverse events(2 year)
  • Response Number of patients with a response to protocol treatment(2 year)
  • Pharmacokinetics Number of patients with germline DNA sequence(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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