A multicentre phase IIa study to evaluate the efficacy and tolerability of ModraDoc006/r in patients with recurrent or metastatic HER-2 negative breast cancer, suitable for treatment with a taxane - M18DMB

Modra Pharmaceuticals B.V.0 个研究点目标入组 24 人2018年9月7日

适应症recurrent/ metastatic HER-2 negative breast cancer, suitable for treatment with a taxane Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: recurrent/ metastatic HER-2 negative breast cancer, suitable for treatment with a taxane
发起方: Modra Pharmaceuticals B.V.
入组人数: 24
状态: 进行中（未招募）
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2018年9月7日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

研究者

发起方

Modra Pharmaceuticals B.V.

入排标准

入选标准

•1\.Able to give written informed consent and to comply with the protocol
•2\.Histologically\- or cytologically confirmed diagnosis of recurrent or metastatic HER\-2 negative breast cancer
•3\.Female of age 18 years or above
•4\.Patients who are eligible to receive a taxane as monotherapy as 1st\-3rd line of therapy for recurrent or metastatic breast cancer. A maximum of two previous lines of chemotherapy is allowed (including experimental i.e. non\-registered chemotherapy alone or in combination). Re\-treatment with one of the same drugs after treatment interruption for reasons of patient preference and/or progression of disease counts as a new treatment
•5\.WHO performance status of 0, 1 or 2 (Appendix II)
•6\.Estimated life expectancy of at least 12 weeks
•7\.Resolution of toxicity of prior therapy to \< grade 2 (except for alopecia and transaminases in case of liver metastases) as defined by CTCAE v5\.0
•8\.Evidence of measurable disease present at baseline as defined by RECIST v1\.1
•9\.Able and willing to swallow oral medication
•10\.Able and willing to undergo radiologic scans (CT scan, or MRI if CT is contraindicated)

排除标准

•1\.Systemic chemotherapy and radiation therapy within the last 4 weeks, endocrine based therapy and CDK4/6 inhibitors within 1 week prior to first dose of ModraDoc006/r. Single dose palliative radiation for pain relieve is allowed until one week prior to start with ModraDoc006/r (these lesions are not to be included as target lesions)
•2\.Any treatment with investigational drugs (or investigational device) within 21 days prior to receiving the first dose of ModraDoc006/r
•3\.Previous treatment with a taxane for recurrent or metastatic breast cancer
•4\.Major surgical procedures within 21 days prior to providing informed consent
•5\.Active acute or chronic infection, which is not controlled by appropriate medication (at the discretion of the treating physician)
•6\.Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III or IV
•7\.Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the Investigator would impair study compliance
•8\.Any medical condition that in the opinion of the Investigator would contra\-indicate or preclude participation within the clinical trial, or would put the patient at high risk for treatment\-related complications
•9\.Previous malignancies within the last three years other than breast carcinoma, except successfully treated squamous/basal cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix
•10\.Patients with symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks are allowed to enrol. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti\-epileptic drugs or corticosteroid treatment indicated for brain metastasis