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

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ClinicalTrials.gov Identifier: NCT00412412
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : June 8, 2012
Sponsor:
Information provided by:
Biogen

Tracking Information
First Submitted Date  ICMJE December 15, 2006
First Posted Date  ICMJE December 18, 2006
Last Update Posted Date June 8, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00412412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
Official Title  ICMJE 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
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: CNF2024
    Oral doses of CNF2024 as specified in the protocol.
    Other Name: BIIB021
  • 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)
Study Arms  ICMJE
  • Experimental: A
    Patients with HER2- Breast Cancer
    Intervention: Drug: CNF2024
  • Experimental: B
    Patients with HER2+ Breast Cancer
    Intervention: Drug: CNF2024 + trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2010)
34
Original Enrollment  ICMJE
 (submitted: December 15, 2006)
50
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00412412
Other Study ID Numbers  ICMJE 120BC101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Morrissey, Quintiles
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biogen
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP