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A Study Inhibiting Telomerase to Reverse Trastuzumab Resistance in HER2+ Breast Cancer

NCT01265927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-10-27

No results posted yet for this study

Summary

A study to evaluate safety and biologic effects of giving GRN163L in combination with trastuzumab in patients diagnosed with HER2+ metastatic breast cancer that is resistant to therapy with trastuzumab.

Conditions

  • Breast Neoplasms

Interventions

DRUG

GRN163L in combination with trastuzumab

GRN163L will be administered in escalating dose cohorts on Day 1 of each 21-day cycle prior to trastuzumab infusion. Trastuzumab will be a administered day 1 of each 21-day cycle after GRN163L. There will be a 30 minute observation period between the end of the GRN163L infusion and the beginning of the trastuzumab infusion.

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Geron Corporation

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Kathy Miller, MD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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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 NCT01265927 on ClinicalTrials.gov