Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
NCT ID: NCT00817362
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
29 participants
INTERVENTIONAL
2009-03-31
2011-05-31
Brief Summary
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Detailed Description
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IPI-504 is an HSP90 inhibitor and is chemically related to 17-AAG and it has been studied in a clinical trial in combination with trastuzamab and a response rate of 26% (7/27) was demonstrated in patients with pretreated, HER2-positive breast cancer. These data provide a strong scientific rationale for clinical testing of IPI-504 plus trastuzumab in patients with pretreated, locally advanced or metastatic HER2-positive breast cancer
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPI-504 and Trastuzumab
IPI-504 IV infusion 300 mg/m2 once weekly in combination with trastuzumab infusion every 3 weeks. (Continuous schedule)
Three week cycle with IPI-504 twice per week for 2 weeks and trastuzumab once per cycle followed by one week without treatment.
Trastuzumab IV infusion 8 mg/kg as the first dose of trastuzumab, followed by trastuzumab 6 mg/kg every 3 weeks. Subjects whose last dose of trastuzumab was \<4 weeks prior to study entry will receive 6 mg/kg as the first dose of trastuzumab. For all additional cycles in Stage 1, trastuzumab will be administered with the first dose of IPI-504.
IPI-504 and trastuzumab will be administered for all cycles. Until progression or unacceptable toxicity develops.
IPI-504
IPI-504 IV infusion 300 mg/m2
Trastuzumab
Trastuzumab IV infusion 8 mg/kg as the first dose of trastuzumab, followed by trastuzumab 6 mg/kg every 3 weeks. Subjects whose last dose of trastuzumab was \<4 weeks prior to study entry will receive 6 mg/kg as the first dose of trastuzumab. For all additional cycles in Stage 1, trastuzumab will be administered with the first dose of IPI-504.
Interventions
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IPI-504
IPI-504 IV infusion 300 mg/m2
Trastuzumab
Trastuzumab IV infusion 8 mg/kg as the first dose of trastuzumab, followed by trastuzumab 6 mg/kg every 3 weeks. Subjects whose last dose of trastuzumab was \<4 weeks prior to study entry will receive 6 mg/kg as the first dose of trastuzumab. For all additional cycles in Stage 1, trastuzumab will be administered with the first dose of IPI-504.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pedro Santabarbara, MD
Role: STUDY_DIRECTOR
Infinity Pharmaceuticals, Inc.
Locations
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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
Countries
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Other Identifiers
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IPI-504-07
Identifier Type: -
Identifier Source: org_study_id