Metastatic Breast CancerPhase 1NCT00983424
Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer
A Phase 1 study testing Cyclosporins and nab-paclitaxel in people with Metastatic Breast Cancer, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Cyclosporins and nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2013
- Phase
- Phase 1
- 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
- Female or male patients with adenocarcinoma of the breast with metastatic disease.
- Patients may have evaluable or measurable disease.
- Age > 18 years.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Able to swallow and retain oral medication.
Who cannot join
- Patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is allowed.
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
- Patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cyclosporine A or nab-paclitaxel.
- Pregnant or lactating (Cyclosporine A is excreted into breast milk) females
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- HIV-positive patients are excluded since Cyclosporine A may result in further immunosuppression
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
About this study
Official title: A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer
The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.
Read the detailed description
Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered investigational which means it has not been approved by the US Food and Drug Administration, FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly 3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth. Participants will continue to receive study treatment as long as their tumor responds. If the tumor does not respond or the participant experience severe side effects from study treatment, she will be removed from the study and offered other therapies, if that is appropriate.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Cyclosporins, nab-paclitaxel
- Keywords
- 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.
CyclosporinsDrug
Also called Neoral, Gengraf
dose escalation, administered orally twice a day
nab-paclitaxelDrug
100 mg/m2 IV days 1, 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Cyclosporine A + nab-paclitaxel Receives: Drug: Cyclosporins; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC).
Measured: labs drawn weekly
To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients.
Measured: at study completion (estimated at 2 years)
Secondary outcomes (1)
To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.
Measured: every 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Avon Foundation
- Responsible party
- Sponsor
- Investigators
- William Gradishar, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983424
- Sponsor's protocol ID
- NU 08B7
- Other IDs
- STU00015585, NCI-2011-00223
- Status last verified
- Sep 2013
- First submitted
- 22 Sep 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00983424
- Acronym / sponsor ID
- NU 08B7
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Avon Foundation
- Study start
- Feb 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Sep 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 research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.
Detailed description
Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered investigational which means it has not been approved by the US Food and Drug Administration, FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly 3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth. Participants will continue to receive study treatment as long as their tumor responds. If the tumor does not respond or the participant experience severe side effects from study treatment, she will be removed from the study and offered other therapies, if that is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Cyclosporins, Drug: nab-paclitaxelCyclosporine A + nab-paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male patients with adenocarcinoma of the breast with metastatic disease.
- Patients may have evaluable or measurable disease.
- Age > 18 years.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Able to swallow and retain oral medication.
Key exclusion criteria (7 listed)
- Patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is allowed.
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
- Patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cyclosporine A or nab-paclitaxel.
- Pregnant or lactating (Cyclosporine A is excreted into breast milk) females
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 |
|---|---|---|
| CyclosporinsAlso: Neoral, Gengrafdose escalation, administered orally twice a day | Drug | Treatment arm |
| nab-paclitaxel100 mg/m2 IV days 1, 8 and 15 | Drug | Treatment arm |
Primary outcome
To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC).
Time frame: labs drawn weekly
To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients.
Time frame: at study completion (estimated at 2 years)
1 secondary outcome
To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.
Time frame: every 6-8 weeks
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 16 Sep 2013.
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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.
William Gradishar, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclosporins and nab-paclitaxel in people with Metastatic Breast Cancer, run by Northwestern University at 1 site 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 5 inclusion and 7 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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?
To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC). (time frame: labs drawn weekly). The study lists 2 primary outcomes in all. 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 16 Sep 2013.