Cabozantinib for Metastatic Triple Negative BrCa
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This research study is Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved XL184 for use in patients, including people with your type of cancer.
XL184 is a drug that may stop cancer cells from growing. It is a small molecule kinase inhibitor that inhibitors met and VEGFR2, as well as other targets. This drug has been used in Phase I studies in humans and laboratory experiments, and information from those other research studies suggests that this drug may help to slow tumor progression in this research study. This drug has also been used in a phase II study for breast cancer patients (a randomized discontinuation trial) suggesting good benefit for this group of patients.
In this research study, we are looking at the anti-tumor effects of XL184 in metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: XL184 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer |
- Evaluation of XL184 based on objective response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the activity of XL184, as defined by objective response rate (ORR) in patients with triple-negative metastatic breast cancer
- Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Evaluation of Progression Free Survival
- c-Met and phospho c-Met expression [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate c-Met and phospho c-Met expression in archival tumor tissue
- Incidence of c-Met amplified circulating tumor cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
- Evaluation of potential serum biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]Evaluate potential serum biomarkers of XL184
- Evaluate PTEN loss and PI3K mutations [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate PTEN loss and PI3K mutations in archival tumor tissue
- Evaluate change in radiotracer uptake within tumor site [ Time Frame: 2 years ] [ Designated as safety issue: No ]Evaluate if the percent change in radiotracer uptake within the tumor site(s) from baseline to the first and second follow-up FDG-PET/CT correlates RECIST response
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2013 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Treatment Arm
XL184, taken orally once per day
|
Drug: XL184
Other Name: Cabozantinib
|
Detailed Description:
In order to determine if you are eligible to participate in this study you will need to undergo some tests and procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests and procedures recently, they may or may not have to be repeated. These tests and procedures include a medical history, physical exam, performance status, assessment of your tumor, blood tests, a urine test and a pregnancy test (if applicable). If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a one month supply of XL184 and a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 3 weeks during which time you will be taking the study drug once per day by mouth.
During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
The investigators will assess your tumor by CT scan or MRI after 6 weeks of treatment, and then every nine weeks you remain on treatment.
The investigators will try to obtain samples of your tumor tissue from a biopsy if you have had one previously. A new biopsy is optional, but may provide researchers with additional information about how XL184 affects the tumor cells.
Participants will receive a pain questionnaire along with information on how to fill in the questionnaire.
The investigators would like to keep track of your medical condition for the rest of your life. The investigators would like to do this by calling you on the telephone once every 6 months to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed invasive breast cancer with stage IV disease
- Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
- May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
- Must have discontinued all biologic therapy at least 14 days before enrollment
- May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
- Must agree to use medically acceptable methods of contraception
- Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
- Able to swallow tablets
Exclusion Criteria:
- Pregnant or breastfeeding
- Received another investigational agent within 14 days prior to enrollment
- Received prior c-Met inhibitor
- Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
- Psychiatric illness or social situation that could limit ability to comply with study requirements
- Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
- Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
- Known to be positive for HIV
- Active infection requiring IV antibiotics at Day 1 of cycle 1
- Uncontrolled, significant intercurrent illness
- Requires chronic concomitant treatment of a strong CYP3A4 inducer
- tumor in contact with, invading or encasing major blood vessels
- Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
Contacts and Locations| Contact: Sara Tolaney, MD, MPH | 6176322335 | stolaney@partners.org |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Sara Tolaney, MD, MPH 617-632-2335 stolaney@partners.org | |
| Principal Investigator: Sara Tolaney, MD, MPH | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Sara Tolaney, MD, MPH 617-632-2335 stolaney@partners.org | |
| Principal Investigator: Sara Tolaney, MD, MPH | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02214 | |
| Contact: Michaela Higgins, MD 617-726-4920 mjhiggins@partners.org | |
| Principal Investigator: Michaela Higgins, MD | |
| Dana-Farber Cancer Institute at Faulkner Hospital | Recruiting |
| Boston, Massachusetts, United States, 02130 | |
| Contact: Erica Mayer, MD, MPH 617-632-3550 emayer@partners.org | |
| Principal Investigator: Erica Mayer, MD, MPH | |
| Principal Investigator: | Sara Tolaney, MD, MPH | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Sara Tolaney, Prinicipal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01738438 History of Changes |
| Other Study ID Numbers: | 12-431 |
| Study First Received: | November 28, 2012 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
Metastatic Triple Negative Stage IV |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013