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Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)

NCT01512199 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-10-18

No results posted yet for this study

Summary

This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects with metastatic breast cancer.

Conditions

Interventions

DRUG

U3-1287

U3-1287: 18 mg/kg administered intravenously once every three weeks

DRUG

Trastuzumab

Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks

DRUG

Paclitaxel

Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks

DRUG

U3-1287

The maximum tolerated dose as determined in Phase 1b portion (between 9 mg/kg and 18 mg/kg) administered intravenously once every three weeks

DRUG

Trastuzumab

Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks

DRUG

Paclitaxel

Paclitaxel: 175 mg/m\^2 administered intravenously once every three weeks

DRUG

Placebo

Placebo: Dose corresponding to U3-1287 administered intravenously once every three weeks

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-01-28
Completion
2015-01-28

Countries

  • Argentina
  • Chile

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01512199 on ClinicalTrials.gov