Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast

In brief

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

Key facts

Study ID

NCT00817362

Run by

Infinity Pharmaceuticals, Inc.

People needed

29

Starts

2009-03-01

Expected to finish

2011-05-01

Last updated by the study team

2012-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs, California, United States
• Boca Raton Comphrensive Cancer Care — Boca Raton, Florida, United States
• Florida Cancer Research Institute — Davie, Florida, United States
• Peachtree Hematology-Oncology Consultants, P.C. — Atlanta, Georgia, United States
• Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Breast Center — New York, New York, United States
• West Cancer Clinic — Memphis, Tennessee, United States
• US Oncology — Dallas, Texas, United States
• Vall d'Hebron Institute of Oncology (V.H.I.O.) — Barcelona, Spain

Full record on ClinicalTrials.gov

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