Breast CancerPhase 1/2NCT00627627
A Study to Evaluate the Antitumor Activity and Safety of IPI-504 in Patients With Advanced Breast Cancer
A Phase 1/2 study testing IPI-504 in people with Breast Cancer, run by MedImmune LLC at 7 sites in United States.
Trial summary
To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IPI-504
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2008to Feb 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lynn Regional Cancer - West Campus
Boca Raton, Florida, 33428
University Hospitals Case Medical Center
Cleveland, Ohio, 44122
Cleveland Clinic Medical Center
Cleveland, Ohio, 44195
"Duke University Med Cntr Breast Oncology Research Program
Durham, North Carolina, 27710
Medical Specialists of the Palm Beaches
Lake Worth, Florida, 33454
Low County Hen/Onc
Mt. Pleasant, South Carolina, 29464
Georgetown Univ Medical Cntr, Lombardi Comprehensive Cancer Center,
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter, Multinational Study to Evaluate the Antitumor Activity and Safety of IPI-504, A Novel Small Molecule Inhibitor of Heat Shock Protein 90(HSP90), in Patients With Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2-Positive(HER2+) Breast Cancer That Has Progressed Despite Prior Her2=Targeted Therapy
To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- IPI-504
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-504Drug
dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IPI-504 Receives: Drug: IPI-504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days after discontinuation of IPI-504
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2010 (estimated)
Why it stopped: Redirect focus of the indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David E. Weng, M.D., PhD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627627
- Sponsor's protocol ID
- MI-CP153
- Status last verified
- Feb 2010
- First submitted
- 21 Feb 2008
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm, Multicenter, Multinational Study to Evaluate the Antitumor Activity and Safety of IPI-504, A Novel Small Molecule Inhibitor of Heat Shock Protein 90(HSP90), in Patients With Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2-Positive(HER2+) Breast Cancer That Has Progressed Despite Prior Her2=Targeted Therapy
- ClinicalTrials.gov ID
- NCT00627627
- Acronym / sponsor ID
- MI-CP153
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Redirect focus of the indication
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2010 (estimated)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IPI-504IPI-504 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPI-504dose of 400 mg/m2 as a 30-60 minute IV infusion as part of a 21-day treatment cycle | Drug | 1 |
Primary outcome
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.
Time frame: 30 days after discontinuation of IPI-504
1 secondary outcome
To evaluate other antitumor activities, safety, and PK parameters of IPI-504 in this patient population.
Time frame: 30 days after discontinuation of IPI-504
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E. Weng, M.D., PhD study director
MedImmune LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPI-504 in people with Breast Cancer, run by MedImmune LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days after discontinuation of IPI-504). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2010.