ACTRN12619001527156已完成1 期
Open-label Phase I study investigating the safety and efficacy of Cetuximab and prochlorperazine (STEMetil) combination therapy in patients with metastatic Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer (CESTEM study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
o increase in on-target toxicity seen in first in human combination safety study. A phase 1b dose escalation safety study treating patients with the combination of cetuximab and PCZ has not demonstrated any unexpected toxicity despite reaching full dose cetuximab. Twelve patients with relapsed head and neck SCC, adenoid cystic carcinoma or EGFR over-expressed triple negative breast cancer have received a total of 57 weeks of the combination treatment. No SAEs or grade 3/4 toxicities attributable to the combination have been seen. Toxicity to date has included grade 1 sedation, akathisia and orthostatic hypotension related to PCZ and resolved within 24 hours. Cetuximab-related rash was observed in ~70% of patients who completed trial. No haematologic toxicity due to the drug combination has been recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Radiological and/or histologically confirmed relapsed Head and Neck Squamous Cell Carcinoma/Triple Negative Breast Cancer/Adenoid Cystic Carcinoma of the head and neck region.
- •2.Predicted life expectancy of greater than three months
- •3.Male or female greater than or equal to 18 years of age
- •4.ECOG performance status 0-2
- •5.Provide informed consent
- •6.Able to commit to 4 hours in the clinic and 24 hours without driving and operating machinery
- •7.Female patients of child bearing potential will be required to have a negative pregnancy test prior to entry on the study and be required to practice an effective form of contraception.
- •8.TNBC patients: histologically confirmed tumour overexpression of EGFR
排除标准
- •1.Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
- •2.Known hypersensitivity to EGFR inhibitors.
- •3.Clinically significant cardiovascular disease (including myocardial infarction,
- •unstable angina, symptomatic congestive heart failure, serious uncontrolled
- •cardiac arrhythmia) less than or equal to 1 year before enrolment/randomization.
- •4.History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
- •evidence of interstitial lung disease previous imaging.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- •6.On drugs that cause long QTc
- •7.History of prolonged QT interval or prolonged QT interval on baseline ECG
- •8.Systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 50 mmHg in two consecutive blood pressure readings within the 1 hour prior to study drug administration.
- •9.Previous reaction to antipsychotic medications
- •10.Parkinsons disease or other chronic extrapyramidal conditions.
- •11.Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •12.Subject (male or female) is not willing to use highly effective methods of
- •contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- •13.High risk for poor compliance.
- •14.Any uncontrolled concurrent medical condition that may interfere with the
- •interpretation of study results.
研究者
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