Phase I/II trial of S 81694 administered intravenously in;combination with paclitaxel to evaluate the safety,;pharmacokinetic and efficacy in metastatic breast cancer - Phase I/II trial of S81694 plus paclitaxel in metastatic Breast Cancer

Servier R&D Benelux0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

Trial ended prematurely

•For Phase I :;- Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therap

•- Other active malignancy within the last 3 years (except for basal cell carcinoma or a non-invasive/in situ cervical cancer or intra-mucosal gastro-intestinal cancers that were treated curatively);;- Presence of grade * 2 toxic effects (excluding alopecia) due to prior cancer therapy;;- Known hypersensitivity to the IMP (S 81694 and paclitaxel) or their excipients;;- Evidence of peripheral neuropathy of grade 2 or higher;;- Participant previously received paclitaxel and discontinued due to toxicity related to paclitaxel;;- Participant known as refractory to taxanes;;- Any prior cancer therapy within 4 weeks before the first IMP administration;;- Participant with current, serious, uncontrolled infections;;- Participant with brain metastasis or leptomeningeal metastasis (except patients with brain metastasis that have been stable post-radiation therapy and who are off steroids for > 2 months);;- History of cardiac disease;;- Uncontrolled arterial hypertension;;- Presence of risk factors for torsades de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome);;- Any clinically significant medical condition (e.g. organ dysfunction) or laboratory abnormality likely to jeopardize the patient*s safety or to interfere with the conduct of the study, in the investigator*s opinion.

发起方