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CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer

NCT00412412•Biogen

View on ClinicalTrials.gov

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

Detailed Description

A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years at the time of informed consent.
•Male and female subjects with confirmed HER2 adenocarcinoma of the breast with advanced disease (advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies) who have had disease progression on at least one standard hormonal or chemotherapy regimen for advanced breast cancer or who have refused standard therapies.
•Evaluable disease either by measurable disease (RECIST) or nonmeasurable disease.
•ECOG ≤2.
•Required Laboratory Values:ANC ≥1500 cells/mm3,platelet count ≥100,000 cells/mm3,hemoglobin ≥9 gm/L; Glucose \>3.3 mmol/L, sodium \>130 mmol/L, calcium \>2.0 mmol/L.
•Plasma cortisol and ACTH levels that are not suggestive of adrenal insufficiency.
•Normal electrocardiogram (ECG) with QTc ≤450 msec for men and ≤470 msec for women.
•Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first study drug administration.
•Age ≥18 years at the time of informed consent.
•Male and female subjects with confirmed HER2+ (IHC 3+ or IHC 2+/FISH+) adenocarcinoma of the breast with advanced disease that have had disease progression on at least 1 standard hormonal or chemotherapy regimen for advanced metastatic breast cancer. Advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies.
+7 more criteria

Exclusion Criteria

•Prior antitumor therapies including prior experimental agents or approved antitumor therapies, within 1 month.
•Active infection requiring intravenous (IV) antibiotic treatment.
•History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix.
•Concurrent severe or uncontrolled diabetes and/or other medical disease
•Problems with swallowing or malabsorption.
•History of major surgery to small intestine.
•Prior treatment with Hsp90 inhibitors.
•History of central nervous system (CNS) metastasis.
•Prior antitumor therapies, including prior experimental agents or approved antitumor therapies, within 1 month.
•Active infection requiring intravenous (IV) antibiotic treatment.
+8 more criteria

Locations (3)

Research Site

Tampa, Florida, United States

Research Site

New York, New York, United States

Research site

Houston, Texas, United States

Key Dates

Start Date

December 1, 2007

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

June 8, 2012

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

CNF2024

DRUG

CNF2024 + trastuzumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer