Phase I/II trial of S 81694 administered intravenously in;combination with paclitaxel to evaluate the safety,;pharmacokinetic and efficacy in metastatic breast cancer
- Conditions
- metastatic breast cancer10006291
- Registration Number
- NL-OMON46450
- Lead Sponsor
- Servier R&D Benelux
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I objectives:<br /><br>- To determine the safety profile and tolerability of S 81694 given in<br /><br>combination with paclitaxel by assessment of the DLT and the MTD based on<br /><br>safety data described using Common Terminology Criteria for Adverse Events<br /><br>(NCI-CTCAE) version 4.03 in patients with mBC,<br /><br>- To establish the recommended phase II dose (RP2D) of S 81694 in combination<br /><br>with paclitaxel.<br /><br>Phase II objectives: To evaluate Progression Free Survival (PFS).</p><br>
- Secondary Outcome Measures
Name Time Method