CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study

NCT00412412 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-06-08

No results posted yet for this study

Summary

The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to:

* find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
* measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
* determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing

Conditions

Interventions

DRUG

CNF2024

Oral doses of CNF2024 as specified in the protocol.

DRUG

CNF2024 + trastuzumab

Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00412412 on ClinicalTrials.gov