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

NCT00412412 | Completed Phase 1

• 1 other identifier: 120BC101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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

Breast Cancer

Keywords

Cancer of Breast; Cancer of the Breast

Outcome Measures

Primary Outcomes (1)

• Clinical and laboratory safety assessments

  30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1

Study Arms (2)

A

EXPERIMENTAL

Patients with HER2- Breast Cancer

Drug: CNF2024

B

EXPERIMENTAL

Patients with HER2+ Breast Cancer

Drug: CNF2024 + trastuzumab

Interventions

CNF2024 DRUG

Oral doses of CNF2024 as specified in the protocol.

Also known as: BIIB021

A

CNF2024 + trastuzumab DRUG

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

Also known as: BIIB021 (CNF2024), Herceptin (trastuzumab)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects must have progressed either within 3 months following last dose of adjuvant trastuzumab treatment or progressed following trastuzumab based therapies for metastatic disease.
• Measurable disease by RECIST or evaluable 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.

You may not qualify if:

• 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.
• 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.
• Cardiac left ventricular function with resting ejection fraction \<50%, assessed by either ECHO or MUGA.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

New York, New York, 10021, United States

Location

Research site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 18, 2006
• Study Start: December 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 8, 2012

Record last verified: 2011-12

Locations

US (3)