Trials / Completed
CompletedNCT03411161
S 81694 Plus Paclitaxel in Metastatic Breast Cancer
Phase I/II Trial of S 81694 Administered Intravenously in Combination With Paclitaxel to Evaluate the Safety, Pharmacokinetic and Efficacy in Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Institut de Recherches Internationales Servier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combination therapy (S81694 + paclitaxel) phase I | Dose escalation S 81694 (IV); paclitaxel started at 80 mg/m²,(IV) |
| DRUG | Paclitaxel | Paclitaxel (IV) at 80 mg/m²/week |
| DRUG | Combination therapy (S81694 + paclitaxel) phase II | S 81694 (IV) at RP2D; paclitaxel (IV) at 80 mg/m²/week |
Timeline
- Start date
- 2018-01-04
- Primary completion
- 2020-06-08
- Completion
- 2020-06-08
- First posted
- 2018-01-26
- Last updated
- 2021-05-25
Locations
6 sites across 4 countries: Belgium, France, Japan, Netherlands
Source: ClinicalTrials.gov record NCT03411161. Inclusion in this directory is not an endorsement.