We will treat patients with locally advanced or metastatic gastric cancer or adenocarcinoma of the gastro-esophageal junction with no curable treatment option. MedDRA version: 17.0 Level: LLT Classification code 10017770 Term: Gastric carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Votrient 200 mg
Product Name: Pazopanib
Product Code: GW786034
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PAZOPANIB
CAS Number: 444731-52-6
Current Sponsor code: GW786034
Conc
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: written informed consent, Age = 18 years or legal age of consent if greater than 18 years, Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either metastatic or locally advanced disease, incurable by operation, ECOG performance status of =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Prior malignancy, overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive, known hypersensitivity against 5-FU, leukovorin,oxaliplatin or other platinum compounds or pazopanib, central nervous system (CNS) metastases, clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal, significant gastrointestinal abnormalities that may affect absorption of investigational product, uncontrolled infection, corrected QT interval (QTc) > 480 msecs using Bazett’s formula, history of severe cardiovascular problems or cerebrovascular accidents (TIA, stroke for example), poorly controlled hypertension, prior major surgery or trauma within 28 days prior to first dose of study drug, evidence of active bleeding or bleeding diathesis, hemoptysis, intake of strong CYP3A4-inhibitors, treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib or chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib, any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia, grade 3 or 4 diarrhea, peripheral polyneuropathy > NCI Grade, pregnant or lactating women, men or woman who are planning a pregnancy within the next six months, participation in another clinical trial with investigational agents within the last 30 days prior to study start, patient is detained in a psychiatric unit or imprisoned, patient is a colleague or employed by the study investigator or by an involved institution including the sponsor of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression free survival rate at 6 months;Secondary Objective: progression free survival rate at 9 and 12 months, median progression free survival, response rate, duration of response, toxicity, tolerability, overall survival, time to treatment failure, evaluation of the predictive and prognostic relevance of biomarkers ;Primary end point(s): Progression free survival rate at 6 months;Timepoint(s) of evaluation of this end point: clinical visit and CT-scan week 26 +/- 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): progression free survival rate at 9 and 12 months, median progression free survival, response rate, duration of response toxicity, tolerability, overall survival, time to treatment failure, evaluation of the predictive and prognostic relevance of biomarkers ;Timepoint(s) of evaluation of this end point: - progression free survival rate: evaluation after 9 and 12 month - median progression free survival: clinical visit every 1-4 weeks and CT-scan every 8 weeks until progression - response rate and duration of response: CT-scan and tumor markers every 8 weeks - toxicity, tolerability: evaluation every visit - evaluation of predictive and prognostic relevance of biomarkers: "day 1 of every cycle during chemotherapie (every two weeks) and day 1 every 4 weeks during pazopanib maintenance therapy or every 4 weeks during observation time before documented progress for patients in Arm B or after discontinuing chemotherapy for any reason before disease progression. Collection of blood samples is planned to be performed until disease progression. | — |
Countries
Germany
Contacts
Public ContactDr. Peter Thuß-Patience
Charité - Universitätsmedizin Berlin
Outcome results
None listed