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A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of IPI-504 in Combination With Trastuzumab in Patients With Pretreated, Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast

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Trial Information

A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of IPI-504 in Combination With Trastuzumab in Patients With Pretreated, Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer


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 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


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to evaluate overall response rate, safety, and tolerability of IPI-504 plus trastuzumab in patients with pretreated, locally advanced or metastatic HER2 positive breast cancer

Outcome Time Frame:

After initial 20 patients are enrolled and treated for one cycle - if less that 33% of the subjects experience a dose limiting toxicity an additional 26 subjects will be enrolled

Safety Issue:

Yes

Principal Investigator

Pedro Santabarbara, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IPI-504-07

NCT ID:

NCT00817362

Start Date:

March 2009

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • HER2 Positive Breast Cancer
  • Metastatic Breast Cancer
  • Cancer of the Breast
  • Breast Cancer
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • HER2 Positive Breast Cancer
  • Cancer of the breast
  • Trastuzumab
  • Herceptin
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Comprehensive Cancer Center at Desert Regional Medical CenterPalm Springs, California  92262
West Cancer ClinicMemphis, Tennessee  38120
Weill Cornell Breast CenterNew York, New York  10021
US OncologyHouston, Texas  77060
Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3500
Peachtree Hematology-Oncology Consultants, P.C.Atlanta, Georgia  30309
Florida Cancer Research InstituteDavie, Florida  
Boca Raton Comphrensive Cancer CareBoca Raton, Florida  33431