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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00412412
First received: December 15, 2006
Last updated: June 7, 2012
Last verified: December 2011
  Purpose

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

Condition Intervention Phase
Breast Cancer
Drug: CNF2024
Drug: CNF2024 + trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Clinical and laboratory safety assessments [ Time Frame: 30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1 ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: December 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patients with HER2- Breast Cancer
Drug: CNF2024
Oral doses of CNF2024 as specified in the protocol.
Other Name: BIIB021
Experimental: B
Patients with HER2+ Breast Cancer
Drug: CNF2024 + trastuzumab
Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.
Other Names:
  • BIIB021 (CNF2024)
  • Herceptin (trastuzumab)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Group A):

  • 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.

Inclusion Criteria (Group B):

  • 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.
  • Normal 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.

Exclusion Criteria (Group A):

  • 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.

Exclusion Criteria (Group B):

  • 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.
  • Prior treatment with Hsp90 inhibitors.
  • Diabetes treated with insulin.
  • History of CNS metastasis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412412

Locations
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, New York
Research Site
New York, New York, United States, 10021
United States, Texas
Research site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Julie Morrissey, Quintiles
ClinicalTrials.gov Identifier: NCT00412412     History of Changes
Other Study ID Numbers: 120BC101
Study First Received: December 15, 2006
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Cancer of Breast
Cancer of the Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014