Phase I/II trial of S 81694 administered intravenously incombination with paclitaxel to evaluate the safety,pharmacokinetic and efficacy in metastatic breast cancer

Overview

No summary available.

Registry

who.int

Start Date

September 27, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•For Phase I :
•\- Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therapy or for which the standard therapy is considered unsuitable;
•\- Patient must have at least one evaluable or measurable metastatic lesion (lesions as defined by revised Response Evaluation Criteria in Solid Tumors
•For Phase II :
•\- Histologically or cytologically confirmed advanced inoperable triple negative breast cancer with no prior anticancer therapy regimen in metastatic setting;
•\- Patient with a minimum washout period of 12 months following previous taxane based adjuvant therapy;
•\- Patient must have at least one measurable metastatic lesion. Ascites, pleural effusion, and bone metastases are not considered measurable;
•\- Acceptance of pre\-treatment metastatic biopsies for all patients and on\-treatment metastatic biopsies in selected centres.
•For the whole study:
•\- Male or female subjects aged \= 18 years old, or legal age of the majority in the country;

•\- 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;