Breast CancerPhase 2NCT00817362
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
A Phase 2 study testing IPI-504 and Trastuzumab in people with Breast Cancer and HER2 Positive Breast Cancer, run by Infinity Pharmaceuticals, Inc. at 11 sites in 2 countries.
Trial summary
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- IPI-504 and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2009to May 2011
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, 30318
Medical College of Georgia Cancer Center
Augusta, Georgia, 30912
Boca Raton Comphrensive Cancer Care
Boca Raton, Florida, 33431
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
US Oncology
Dallas, Texas, 76022
Florida Cancer Research Institute
Davie, Florida, 33328
West Cancer Clinic
Memphis, Tennessee, 38120
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Weill Cornell Breast Center
New York, New York, 10065
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
About this study
Official title: 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
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
Read the detailed description
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
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast
- Being tested
- IPI-504, Trastuzumab
- Keywords
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive Breast Cancer, Cancer of the breast, Trastuzumab, Herceptin
- 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
IPI-504 IV infusion 300 mg/m2
TrastuzumabDrug
Also called Herceptin
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.
| Study group | Role | What they receive |
|---|---|---|
| IPI-504 and Trastuzumab | Experimental | 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. Receives: Drug: IPI-504; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (1)
Evaluate the progression-free survival (PFS) time to progression (TTP) and overall survival(OS)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionMay 2011
Why it stopped: Limited efficacy response observed during interim analysis.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Santabarbara, MD, Study director, Infinity Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817362
- Sponsor's protocol ID
- IPI-504-07
- Status last verified
- Dec 2012
- First submitted
- 5 Jan 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00817362
- Acronym / sponsor ID
- IPI-504-07
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast
- Keywords
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive Breast Cancer, Cancer of the breast, Trastuzumab, Herceptin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited efficacy response observed during interim analysis.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Jan 2009 (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.
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-504 and Trastuzumab | Experimental | Drug: IPI-504, Drug: TrastuzumabIPI-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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-504IPI-504 IV infusion 300 mg/m2 | Drug | IPI-504 and Trastuzumab |
| TrastuzumabAlso: HerceptinTrastuzumab 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. | Drug | IPI-504 and Trastuzumab |
Primary outcome
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
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
1 secondary outcome
Evaluate the progression-free survival (PFS) time to progression (TTP) and overall survival(OS)
Time frame: One year
Results and safety
The study was stopped early (reason given: Limited efficacy response observed during interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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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.
Pedro Santabarbara, MD study director
Infinity Pharmaceuticals, Inc.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-504 and Trastuzumab in people with Breast Cancer and HER2 Positive Breast Cancer, run by Infinity Pharmaceuticals, Inc. at 11 sites in 2 countries.
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 22 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: stopped early, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Spain. 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 phase mean?
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 stopped early (reason given: Limited efficacy response observed during interim analysis.). Results are not available in the source record.
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?
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 (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). 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 11 Dec 2012.