Metastatic Breast CancerPhase 1NCT01640665
Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors
A Phase 1 study testing Sorafenib and Capecitabine in people with Metastatic Breast Cancer and Gastrointestinal Tumors, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Gastrointestinal Tumors
- What is being tested?
- Sorafenib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2014
- 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
- Age ≥ 18 years.
- Life expectancy of at least 12 weeks (3 months).
- ECOG Performance Status 0 or 1.
- Histologically confirmed unresectable or metastatic breast and/or GI tumors for which curative standard treatments are unavailable
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin > 9.0 g/dl
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- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count > 100,000/mm3
- Total bilirubin < 1.5 times ULN
- ALT and AST < 2.5 times the ULN ( < 5 x ULN for patients with liver involvement)
- GFR > 30 ml/min
- All acute toxic effects (excluding alopecia and neuropathy) of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
- Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
- Subject must be able to swallow and retain oral medication.
- Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Who cannot join
- Metastatic brain or meningeal tumors (unless subject completed definitive therapy more than 1 month previously and is stable off steroids).
- Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Active or clinically significant cardiac disease including:
- Congestive heart failure - New York Heart Association (NYHA) > Class II.
- Active coronary artery disease.
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
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- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
- Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of study enrollment; any other hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks of study enrollment.
- Major surgery, open biopsy or significant traumatic injury within 30 days of first study drug.
- Presence of an active non-healing wound, non-healing ulcer, or bone fracture.
- Thrombotic or embolic events such as a cerebrovascular accident (including transient ischemic attacks) within 3 month of informed consent.
- Anticoagulation with warfarin is not permitted.
- Evidence or history of bleeding diathesis or coagulopathy.
- Subjects who have used strong CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, St. John's Wort [Hypericum perforatum], dexamethasone at a dose of greater than 16 mg daily, or rifampin [rifampicin], and/or rifabutin) within 30 days of trial enrollment.
- Subjects with a history of dihydopyrimidine dehydrogenase (DHPD) deficiency or severe and unexpected reactions to fluropyrimidines.
- Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All relevant cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form).
- History of organ allograft. (Including corneal transplant).
- Known human immunodeficiency virus (HIV) infection or Hepatitis B or C currently undergoing active antiviral treatment.
- Any malabsorption problem.
- Anticancer chemotherapy or immunotherapy during the study is not permitted.
- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
- Women who are pregnant or breast-feeding.
- Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. The drug Capecitabine is approved to treat patients with advanced breast cancer as well as early stage colon cancer.
Read the detailed description
This is a pilot study of Sorafenib combined with Capecitabine in patients with histologically confirmed unresectable or metastatic breast and GI tumors. One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days
- Conditions
- Metastatic Breast Cancer, Gastrointestinal Tumors
- Being tested
- Sorafenib, Capecitabine
- Keywords
- histologically, unresectable, metastatic, Phase 1, Breast Cancer, GI Tumors, Sorafenib, Capecitabine
- Medical subject headings
- Breast Neoplasms, Digestive System Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Sorafenib (Nexavar)
One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses.
CapecitabineDrug
Also called Capecitabine (Xeloda)
Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and Capecitabine | Experimental | One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days Receives: Drug: Sorafenib; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose / Safety
Primary Objectives:
- Safety
- Determination of maximum tolerated dose
Measured: 4 weeks
Secondary outcomes (1)
Response
Secondary Objectives:
- Overall Response Rate
- Duration of Response
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionAug 2014
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 Yale 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Gina Chung, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640665
- Sponsor's protocol ID
- GC0212
- Status last verified
- Sep 2016
- First submitted
- 5 Jun 2012
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT01640665
- Acronym / sponsor ID
- GC0212
- Conditions
- Metastatic Breast Cancer, Gastrointestinal Tumors
- Keywords
- histologically, unresectable, metastatic, Phase 1, Breast Cancer, GI Tumors, Sorafenib, Capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Jul 2012 (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 find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. The drug Capecitabine is approved to treat patients with advanced breast cancer as well as early stage colon cancer.
Detailed description
This is a pilot study of Sorafenib combined with Capecitabine in patients with histologically confirmed unresectable or metastatic breast and GI tumors. One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days
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 Capecitabine | Experimental | Drug: Sorafenib, Drug: CapecitabineOne cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years.
- Life expectancy of at least 12 weeks (3 months).
- ECOG Performance Status 0 or 1.
- Histologically confirmed unresectable or metastatic breast and/or GI tumors for which curative standard treatments are unavailable
- Adequate bone marrow, liver and renal function as assessed by the following:
Key exclusion criteria (24 listed)
- Metastatic brain or meningeal tumors (unless subject completed definitive therapy more than 1 month previously and is stable off steroids).
- Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Active or clinically significant cardiac disease including:
- Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of study enrollment; any other hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks of study enrollment.
- Major surgery, open biopsy or significant traumatic injury within 30 days of first study drug.
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 |
|---|---|---|
| SorafenibAlso: Sorafenib (Nexavar)One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses. | Drug | Sorafenib and Capecitabine |
| CapecitabineAlso: Capecitabine (Xeloda)Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days. | Drug | Sorafenib and Capecitabine |
Primary outcome
Maximum Tolerated Dose / Safety
Time frame: 4 weeks
Primary Objectives: * Safety * Determination of maximum tolerated dose
1 secondary outcome
Response
Time frame: 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 2016.
- Yale Cancer Center WebsiteLink provided by the sponsor.
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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.
Gina Chung, MD principal investigator
Yale 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 Sorafenib and Capecitabine in people with Metastatic Breast Cancer and Gastrointestinal Tumors, run by Yale 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 16 inclusion and 24 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 2016. 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?
Maximum Tolerated Dose / Safety (time frame: 4 weeks). 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 2016.