Metastatic Breast CancerPhase 1/2NCT00764972
Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer
A Phase 1/2 study testing Sorafenib and Vinorelbine in people with Metastatic Breast Cancer, run by McGill University at 1 site in Canada.
Trial summary
This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Sorafenib and Vinorelbine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Dec 2011
- 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 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women affected by histologically proven metastatic breast cancer.
- Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.
- Female, age ≥ 18.
- Documented measurable disease by appropriate radiologic imaging according to RECIST criteria (see Appendix E). Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation.
- ECOG performance status 0-1 (see Appendix B)
- Life expectancy > 6 months.
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- Adequate bone marrow function, as indicated by:
- Hemoglobin ≥ 90 g/L
- Neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit of normal and/or Creatinine Clearance calculated as >50% lower normal limit, or estimated as ≥ 50 ml/min (Appendix C).
- Adequate liver function, as indicated by:
- bilirubin ≤ 1.5 times upper normal limit;
- AST and ALT ≤ 2 times upper normal limit.
- Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).
- No therapy for breast cancer in the 4 weeks preceding the therapy start.
- Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.
- Patient able to understand and give written informed consent.
Who cannot join
- Patients with locally advanced breast cancer or stage IIIb only.
- Presence of only non-measurable disease.
- Previous (neo)adjuvant chemotherapy with vinorelbine.
- Any previous anti-angiogenic therapy.
- Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments or radiotherapy for metastatic disease are allowed.
- Radiotherapy, chemotherapy or hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.
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- Major surgery within 4 weeks of first study treatment, or minor surgery (including placement of an access device) within 7 days of therapy start.
- Presence of life-threatening disease or central nervous system localizations.
- Evidence of HER-2 positive breast cancer, defined as FISH-positive for amplification or score 3+ by immunohistochemistry.
- Any other possibly active primary tumor, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Clinically significant hepatic disease with respect to hepatitis B, hepatitis C, cirrhosis or other liver diseases.
- Uncontrolled bacterial, viral or fungal infection.
- Previous history of ischemic disease.
- Patients with previous history of thrombo-embolic events, or with documented risk factors for thrombotic disease other than cancer.
- History of gross hemorrhage within the past 6 months (e.g., hemoptysis or hematuria requiring medical intervention).
- Uncontrolled hypertension.
- Other serious medical conditions, such as uncontrolled cardiac disease, severe pulmonary disease, uncontrolled diabetes.
- Patient exhibiting confusion or disorientation.
- Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.
- Patient is pregnant, or is breast-feeding, or is unwilling to use adequate contraception.
- Failure to give informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Lawrence Panasci, 514-340-8248, lpanasci@hotmail.com
Cristiano Ferrario, 514-340-8248, cristianoferrario@gmail.com
About this study
Official title: A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer
This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer.
The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients.
Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Sorafenib and Vinorelbine
- Keywords
- To evaluate the use of sorafenib added to vinorelbine chemotherapy, to find out which are the doses of two drugs can be safely combined
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib and VinorelbineDrug
Also called BAY 43-9006
vinorelbine, administered as a brief infusion twice every three weeks (on day 1 and 8 of 21-day cycles);
sorafenib, that you will take orally every day, at the dosage that your study doctor will prescribe.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and Vinorelbine | Experimental | Not described Receives: Drug: Sorafenib and Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence Panasci, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764972
- Sponsor's protocol ID
- McG 0713
- Status last verified
- Oct 2008
- First submitted
- 30 Sep 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrario C, Strepponi I, Esfahani K, Charamis H, Langleben A, Scarpi E, Nanni O, Miller WH Jr, Panasci LC. Phase I/II Trial of Sorafenib in Combination with Vinorelbine as First-Line Chemotherapy for Metastatic Breast Cancer. PLoS One. 2016 Dec 19;11(12):e0167906. doi: 10.1371/journal.pone.0167906. eCollection 2016.
PubMed 27992451
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00764972
- Acronym / sponsor ID
- McG 0713
- Conditions
- Metastatic Breast Cancer
- Keywords
- To evaluate the use of sorafenib added to vinorelbine chemotherapy, to find out which are the doses of two drugs can be safely combined
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Oct 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 IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer.
The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients.
Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and Vinorelbine | Experimental | Drug: Sorafenib and Vinorelbine |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Women affected by histologically proven metastatic breast cancer.
- Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.
- Female, age ≥ 18.
- Documented measurable disease by appropriate radiologic imaging according to RECIST criteria (see Appendix E). Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation.
- ECOG performance status 0-1 (see Appendix B)
Key exclusion criteria (21 listed)
- Patients with locally advanced breast cancer or stage IIIb only.
- Presence of only non-measurable disease.
- Previous (neo)adjuvant chemotherapy with vinorelbine.
- Any previous anti-angiogenic therapy.
- Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments or radiotherapy for metastatic disease are allowed.
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 |
|---|---|---|
| Sorafenib and VinorelbineAlso: BAY 43-9006vinorelbine, administered as a brief infusion twice every three weeks (on day 1 and 8 of 21-day cycles); sorafenib, that you will take orally every day, at the dosage that your study doctor will prescribe. | Drug | Sorafenib and Vinorelbine |
Primary outcome
Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
- Derived from this study: PubMed 27992451Ferrario C, Strepponi I, Esfahani K, Charamis H, Langleben A, Scarpi E, Nanni O, Miller WH Jr, Panasci LC. Phase I/II Trial of Sorafenib in Combination with Vinorelbine as First-Line Chemotherapy for Metastatic Breast Cancer. PLoS One. 2016 Dec 19;11(12):e0167906. doi: 10.1371/journal.pone.0167906. eCollection 2016.
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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.
Lawrence Panasci principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sorafenib and Vinorelbine in people with Metastatic Breast Cancer, run by McGill University at 1 site in Canada.
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 18 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 21 Oct 2008. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Panasci (514-340-8248, lpanasci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed complete response (CR) or partial response (PR), defined according to RECIST criteria, persisting 4 weeks after the initial documentation.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764972, which also lists 1 linked publication.
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 21 Oct 2008.