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S 81694 Plus Paclitaxel in Metastatic Breast Cancer

NCT03411161 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-05-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Principal Investigators

  • Mario CAMPONE, Pr · Institut de Cancérologie de l'Ouest site Saint Herblain

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2020-06-08
Completion
2020-06-08

Countries

  • Belgium
  • France
  • Japan
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411161 on ClinicalTrials.gov