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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Breast Cancer (mBC) and metastatic Triple Negative Breast Cancer (mTNBC)
Sponsor: Institut de Recherches Internationales Servier
Enrollment: 120
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

February 5, 2018

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;