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Trastuzumab in Combination With AMG 479 in HER-2 Overexpressing MBC Progressing on Trastuzumab

NCT01479179 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-10-26

No results posted yet for this study

Summary

The goal of Phase 1 of this clinical research study is to test the safety and tolerability of AMG 479 when given with trastuzumab.

The goal of Phase 2 of this clinical research study is to learn if the combination of AMG 479 and trastuzumab can help to control breast cancer.

AMG 479 is designed to block tumor cells from growing and spreading.

Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell.

Conditions

Interventions

DRUG

AMG 479

Phase I Starting Dose: 18 mg/kg by vein on Day 1 of a 21 day cycle. Phase II Starting Dose: Maximum tolerated dose from Phase I.

DRUG

Trastuzumab

Phase I and II Starting Dose: 8 mg/kg by vein on Day 1 of a 21 day cycle. Phase I and II Maintenance Dose: 6 mg/kg by vein on Day 1 of a 21 day cycle.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Francisco J. Esteva, MD,PHD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-11-30

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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 NCT01479179 on ClinicalTrials.gov