Carcinoma Breast Stage IVPhase 2NCT00669565
Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
A Phase 2 study testing Bavituximab in people with Carcinoma Breast Stage IV, run by Peregrine Pharmaceuticals at 9 sites in India.
Trial summary
This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma Breast Stage IV
- What is being tested?
- Bavituximab
- How many people
- 46 participants
- Where
- 9 sitesIndia
- Study dates
- Jul 2008to Aug 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in India for the duration of the study
- Adult females over age 18 years of age with a life expectancy of at least 3 months
- Confirmed breast cancer with evidence of locally advanced or metastatic disease
- Disease that is measurable by radiology imaging
- Ambulatory and capable of all selfcare but unable to carry out any work activities.
- Adequate laboratory results (hematologic, renal, hepatic)
- Negative pregnancy test
Who cannot join
- History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
- Any history of thromboembolic events (clots within blood vessels)
- Ongoing treatment with high doses of anticoagulants
- Use of hormone therapy
- Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
- Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
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- Radiotherapy within 2 weeks entering the study
- Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study
- Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
- Diagnosed and active CNS disease or metastatic lesions
- Major surgery within 4 weeks of starting the study
- Pregnant or nursing
- Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease)
- History of heart disease
- History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids
- Diagnosed with HIV or hepatitis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Rajalakshmi Multispecialty Hospital
Bangalore
Bangalore Institute of Oncology
Banglore
Apollo Specialty Hospitals
Chennai
Nizam's Institute of Medical Sciences
Hyderabaad
Regional Cancer Center
Kerala
Medical College Hospital
Kolkata
Bharath Hospital and Institite of Oncology
Mysore
Curie Manavata Cancer Center
Nashik
Ruby Hall Clinic
Pune
About this study
Official title: A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.
- Conditions
- Carcinoma Breast Stage IV
- Being tested
- Bavituximab
- Keywords
- Locally Advanced or Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BavituximabDrug
Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine the overall response rate (CR+PR)
Measured: Until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma Breast Stage IVStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669565
- Sponsor's protocol ID
- PPHM 0702
- Status last verified
- Mar 2011
- First submitted
- 28 Apr 2008
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00669565
- Acronym / sponsor ID
- PPHM 0702
- Conditions
- Carcinoma Breast Stage IV
- Keywords
- Locally Advanced or Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Apr 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.
This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Living in India for the duration of the study
- Adult females over age 18 years of age with a life expectancy of at least 3 months
- Confirmed breast cancer with evidence of locally advanced or metastatic disease
- Disease that is measurable by radiology imaging
- Ambulatory and capable of all selfcare but unable to carry out any work activities.
Key exclusion criteria (16 listed)
- History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
- Any history of thromboembolic events (clots within blood vessels)
- Ongoing treatment with high doses of anticoagulants
- Use of hormone therapy
- Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
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 |
|---|---|---|
| BavituximabReceive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles. | Drug | – |
Primary outcome
The primary objective of this study is to determine the overall response rate (CR+PR)
Time frame: Until disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bavituximab in people with Carcinoma Breast Stage IV, run by Peregrine Pharmaceuticals at 9 sites in India.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 this study is to determine the overall response rate (CR+PR) (time frame: Until disease progression). 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 24 Mar 2011.