Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer
NCT ID: NCT01238029
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
12 participants
INTERVENTIONAL
2010-10-31
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Capecitabine, Lapatinib, Vinorelbine
Lapatinib and Capecitabine and Vinorelbine
Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lapatinib and Capecitabine and Vinorelbine
Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to comply with the protocol
* ECOG performance status 0-1
* Adequate contraception
* Confirmed Her2/neu-positive, adenocarcinoma of the breast
* At least one measurable lesion according to RECIST 1.1 criteria
* First or second chemotherapy after diagnosis of metastasis
* Lapatinib treatment indicated (adjuvant trastuzumab treatment \<12 months ago or progressive disease with trastuzumab treatment)
* No signs and symptoms of CHF (chronic heart failure), LVEF (left ventricular ejection fraction) at study start at least 55%
* Adequate hepatic and renal function value
* Adequate hematologic function values
Exclusion Criteria
* Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
* Asymptomatic with regards to tumor illness
* Previous treatment with lapatinib, capecitabine or vinorelbine
* Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
* Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
* History of vascular or cardiovascular disease within the past 6 months
* All illnesses that result in malabsorption of oral medication or inability to take oral medication
* Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
* Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
* Concurrent treatment with allopurinol
* Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years
* Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
iOMEDICO AG
INDUSTRY
Arbeitsgemeinschaft fur Internistische Onkologie
OTHER
Arbeitskreis Klinische Studien
OTHER
GlaxoSmithKline
INDUSTRY
Sponsor GmbH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ulrike Soeling, MD
Role: PRINCIPAL_INVESTIGATOR
Goethestr. 47, 34119 , Kassel, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Onkologie Ravensburg
Ravensburg, Baden-Wurttemberg, Germany
Praxisgemeinschaft Dres. Siehl und Söling
Kassel, Hesse, Germany
Onkologische Schwerpunktpraxis
Goslar, Lower Saxony, Germany
Onkologische Schwerpunktpraxis Leer Emden
Leer, Lower Saxony, Germany
Schwerpunktpraxis Hämatologie / Onkologie
Stade, Lower Saxony, Germany
Onkodok (Dr. Rösel und Dr. Depenbusch)
Gütersloh, North Rhine-Westphalia, Germany
Praxis für Hämatologie und Onkologie
Mülheim, North Rhine-Westphalia, Germany
Hämatologisch-onkologische Gemeinschaftspraxis
Münster, North Rhine-Westphalia, Germany
Praxis für Onkologie u. Hämatologie
Neuss, North Rhine-Westphalia, Germany
Onkologische Gemeinschaftspraxis Dörfel/Göhler
Dresden, Saxony, Germany
Onkologische Schwerpunktpraxis
Heidelberg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0907-002
Identifier Type: -
Identifier Source: org_study_id