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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical and laboratory safety assessments

Outcome Time Frame:

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

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

120BC101

NCT ID:

NCT00412412

Start Date:

December 2007

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Cancer of Breast
  • Cancer of the Breast
  • Breast Neoplasms

Name

Location

Research SiteBoca Raton, Florida  
Research SiteAlbany, New York  
Research SiteAbilene, Texas