Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00627627
Other study ID # MI-CP153
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received February 21, 2008
Last updated February 1, 2010
Start date April 2008

Study information

Verified date February 2010
Source MedImmune LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Description:

To evaluate the antitumor activity following treatment with IPI-504 in patients with locally advanced or metastatic HER2+ breast cancer that has progressed despite prior HER2-targeted therapy.


Recruitment information / eligibility

Status Withdrawn
Enrollment 56
Est. completion date
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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:

1. 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;

2. 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;

- AST and ALT = 2.5 ´ upper limit of normal (ULN) or = 5 ´ ULN for patients with liver metastases; total bilirubin = 1.5 ´ ULN [unless due to Gilbert's syndrome (unconjugated hyperbilirubinemia) in which case the bilirubin should be < 3.5mg/dL); hepatic alkaline phosphatase = 2.5 ´ ULN;

- Serum creatinine = 1.5 ´ ULN and calculated creatinine clearance = 30 mL/min;

- Women with central nervous system (CNS) metastases are eligible if they are clinically stable for at least 3 months after the discontinuation of prior corticosteroid therapy;

- Female patients must be of non child-bearing potential or using effective contraception, eg, use of oral contraceptives with an additional barrier method (since the study drug may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, total abstinence, and willing to continue the effective contraception method for 30 days after the last dose of IPI-504; and

- Patients must be able to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

- 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
IPI-504
dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle

Locations

Country Name City State
United States Lynn Regional Cancer - West Campus Boca Raton Florida
United States Cleveland Clinic Medical Center Cleveland Ohio
United States University Hospitals Case Medical Center Cleveland Ohio
United States "Duke University Med Cntr Breast Oncology Research Program Durham North Carolina
United States Medical Specialists of the Palm Beaches Lake Worth Florida
United States Low County Hen/Onc Mt. Pleasant South Carolina
United States Georgetown Univ Medical Cntr, Lombardi Comprehensive Cancer Center, Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To evaluate other antitumor activities, safety, and PK parameters of IPI-504 in this patient population. 30 days after discontinuation of IPI-504 Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2