A Study to Evaluate the Antitumor Activity and Safety of IPI-504 in Patients With Advanced Breast Cancer

NCT00627627 | Withdrawn Phase 1 DMC

• 1 other identifier: MI-CP153
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

Brief Summary

To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the antitumor activity, assessed by ORR which will be determined using RECIST, following treatment with IPI-504 in patients with locally advanced or metastatic HER2+ breast cancer that has progressed despite prior HER2-targeted therapy.

  30 days after discontinuation of IPI-504

Secondary Outcomes (1)

• To evaluate other antitumor activities, safety, and PK parameters of IPI-504 in this patient population.

  30 days after discontinuation of IPI-504

Study Arms (1)

1

EXPERIMENTAL

IPI-504

Drug: IPI-504

Interventions

IPI-504 DRUG

dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women at least 18 years of age at the time of signing the Informed Consent Form;
• Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the patient prior to performing any study-related procedures, including screening visits;
• Pathologically confirmed breast cancer from assessment of primary or metastatic breast cancer;
• Locally advanced or metastatic breast cancer as defined as a T4 primary tumor and Stage IIIB/ IIIC disease or Stage IV disease, respectively, according to the Sixth Edition of the American Joint Committee on Cancer \[AJCC\] TNM System (Appendix A);
• Measurable disease according to RECIST - lesions that can be accurately measured in at least one dimension with longest diameter ³ 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scan or ³ 10 mm with spiral CT scan; the use of chest x-ray is not encouraged, however, it may be used if necessary;
• HER2-expressing primary or metastatic tumor (Grade 3+ staining intensity \[on a scale of 0 to 3\] via IHC assays or HER2 amplification on fluorescence in situ hybridization), with results of the most recent biopsy taken as indicative of HER2 status;
• Progression after treatment with at least 1 but not more than 3 regimens containing trastuzumab or lapatinib (treatment regimens that do not include trastuzumab or lapatinib do not qualify) for adjuvant, neoadjuvant, locally advanced, or metastatic disease with either one of the following stipulations:
• Patients may have received neoadjuvant or adjuvant treatment with prior trastuzumab or lapatinib treatment but must have demonstrated no evidence of disease progression for \>12 months following completion of therapy;
• Patients have received a trastuzumab-based therapy for locally advanced or metastatic disease for a minimum of 9 weeks duration. Patients may have received more than 1 trastuzumab-based combination therapy; Patients have received a lapatinib-based therapy for locally advanced or metastatic diseases for a minimum of 9 weeks duration;
• Resolution of all toxic side effects of prior chemotherapy, radiotherapy or surgical procedures to NCI CTCAE Grade ≤ 1 or patient's baseline;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (see Appendix B);
• Life expectancy of at least 3 months;
• Left ventricular ejection fraction \> 45%;
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; platelet count ≥ 100,000 cells/mm3; hemoglobin ≥ 9.0 g/dL (may be increased to this level with transfusion as long as there is no evidence of active bleeding);
• Prothrombin time or international normalized ratio within normal range (unless a patient is receiving anticoagulation therapy), or PTT within normal range;

You may not qualify if:

• Previous treatment with 17-AAG, 17-DMAG, or other known Hsp90 inhibitor;
• Concurrent radiation or surgery therapy;
• Treatment for breast cancer with any approved or investigational product, including any local or systemic therapy within 4 weeks prior to first dose of IPI-504 in this study;
• Initiation or discontinuation of concurrent medication that alters CYP3A activity within 2 weeks prior to treatment with IPI-504. Patients who are on a stable dose of drugs known to alter CYP3A activity for \> 2 weeks are eligible to enroll;
• Presence of active infection or systemic use of antimicrobials within 72 hours prior to treatment with IPI-504;
• Untreated brain metastases (patients with a history of brain metastases are eligible as long as definitive treatment has been given and patients are clinically stable for at least 3 months after the discontinuation of prior corticosteroid therapy);
• Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study (eg, cardiac disease such as acute coronary syndrome or unstable angina within 6 months, uncontrolled hypertension, arrhythmia requiring medication or mechanical control, conduction system abnormality such as left bundle branch block or second degree heart block, cirrhotic liver disease, cerebrovascular accident, or other conditions);
• Women who are pregnant or lactating;
• Sinus bradycardia (resting heart rate \< 50 bpm) secondary to intrinsic conduction system disease; Patients with sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of the treatment results in normalization of the resting heart rate to within normal limits;
• Screening QTc \> 470 msec, or previous history of QTc prolongation while taking other medications; or
• Active or recent history (within 3 months) of keratitis or keratoconjunctivitis.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (7)

Georgetown Univ Medical Cntr, Lombardi Comprehensive Cancer Center,

Washington D.C., District of Columbia, 20007, United States

Location

Lynn Regional Cancer - West Campus

Boca Raton, Florida, 33428, United States

Location

Medical Specialists of the Palm Beaches

Lake Worth, Florida, 33454, United States

Location

"Duke University Med Cntr Breast Oncology Research Program

Durham, North Carolina, 27710, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44122, United States

Location

Cleveland Clinic Medical Center

Cleveland, Ohio, 44195, United States

Location

Low County Hen/Onc

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David E. Weng, M.D., PhD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: March 3, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2010
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

US (7)