Status:
TERMINATED
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
Lead Sponsor:
Infinity Pharmaceuticals, Inc.
Conditions:
Breast Cancer
HER2 Positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
Detailed Description
Recent clinical data has demonstrated that even in heavily pretreated patients with trastuzumab-refractory HER-2 positive breast cancer, targeting HER2 is efficacious. IPI-504 is an HSP90 inhibitor a...
Eligibility Criteria
Inclusion
- Locally advanced/metastatic breast cancer.
- HER2-expressing primary or metastatic tumor
- Two prior regimens with HER2. Trastuzumab must have been given. No limit to prior therapies
- Measurable disease with RECIST 1.1
- Clinical progression
- LVEF WNL
- ECOG 0 or 1
- Last dose of chemotherapy, radiotherapy, surgery, ablative therapy, tyrosine kinase inhibitor, ≥2 weeks
- Administration of biological therapy ≥4 weeks
- Last dose of trastuzumab must be ≥1, or ≥3 weeks prior to start, if previously administered on an every 3 week schedule.
- Resolution of toxic effects to baseline or Grade 1, except alopecia (NCI CTCAE Version 3.0
- Organ and marrow function:
- Hemoglobin ≥8.0 g/dL
- ANC ≥1200/µL
- Platelets ≥75,000 /µL
- ALT and AST ≤ 1.5 x ULN
- Alkaline phosphatase ≤2.5 x ULN, or ≤3.0 x ULN if secondary to liver metastases.
- Serum bilirubin WNL
- Serum albumin ≥3.0 g/dL
- PT, PTT ≤1.5 x ULN
- Serum creatinine ≤1.5 x ULN
- Negative pregnancy test
Exclusion
- Prior treatment with Hsp90 inhibitor.
- Grade 4 AE secondary to trastuzumab. Grade 3/4 infusion reactions or Grade 3/4 symptomatic heart failure
- Medication/food that is a CYP3A inhibitor or inducer.
- Hx 6 months: cardiac disease - acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident or significant co-morbid condition
- Grade 3 or 4 hemorrhagic event within 6 months.
- HIV positivity
- Baseline QT corrected, QTcF \>470 ms
- Sinus bradycardia \<50 bpm Secondary to pharmacologic therapy may enroll if stopping therapy normalizes heart rate.
- Malignancies within 3 years other than non-melanomatous skin cancers, non-muscle-invasive bladder cancer and carcinoma in situ of cervix.
- Active keratitis or keratoconjunctivitis
- Active brain metastasis (e.g., requiring therapy with steroids or radiation therapy; or with intracranial progression 4 weeks after the completion of radiation therapy) uncontrolled seizure disorder, ongoing spinal cord compression, or carcinomatous meningitis. If clinically stable brain metastasis (previously treated or untreated)are present pt is eligible.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00817362
Start Date
March 1 2009
End Date
May 1 2011
Last Update
December 11 2012
Active Locations (11)
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1
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
2
Boca Raton Comphrensive Cancer Care
Boca Raton, Florida, United States, 33431
3
Florida Cancer Research Institute
Davie, Florida, United States, 33328
4
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, United States, 30318