Advanced Bilary Tract Tumours: Gall bladder cancer and Cholangiocarcinoma MedDRA version: 7.0 Level: LLT Classification code 10028982
Conditions
Interventions
Product Name: Becatecarin
Product Code: XL119
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Becatecarin
CAS Number: 119673-08-4
Current Sponsor code: XL119
Other descriptive name: D
Sponsors
Exelixis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria:· 1. Male and female subjects with advanced histologically confirmed biliary cancer (gall bladder cancer or cholangiocarcinoma) that is not not amenable to conventional surgical approach· 2. 18 years or older· 3. Life expectancy of at least 12 weeks· 4. ECOG Performance Status score 3000/µL; absolute neutrophil count greater than or equal to 1,500/µL; hemoglobin greater than or equal to 9.5 g/dL; platelet count greater than or equal to 100,000/µL; lymphocyte count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria:· 1. Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)· 2. Unstable angina, or class III or IV New York Heart Association heart disease· 3. CNS metastases· 4. Uncontrolled diabetes mellitus· 5. Uncontrolled seizure disorder· 6. Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment· 7. Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation· 8. Pregnant or breast feeding· 9. A known history of human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare overall survival duration for XL119 and 5FU/LV treated subects ;Secondary Objective: 1) To determine time to progressive disease for XL119 and 5FU/LV treated subjects (clinical or radiologic (radiographic only for tumors assessed as measurable at baseline)). 2) To evaluate clinical benefit for XL119 and 5FU/LV treated subjects using ECOG Performance Status and FACT-Hep Quality of Life subscales. An additional measure of efficacy in subjects with measurable disease will be best tumor response. Determination of best-tumor response will be based on objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST) system of unidimensional evaluation. 3) To assess the safety profile of XL119 : (1) serious and nonserious AEs and (2) laboratory evaluations. An Independent Data Monitoring Committee (IDMC) will periodically review serious adverse events, abnormal laboratory tests, futility, and efficacy at two interim analysis meetings. Two interim analyses will be performed after 33% and 50% of the total deaths (516) are reported.;Primary end point(s): The primary efficacy variable will be obtained by determining the overall survival duration, as either, alive, dead, or lost to follow up, at each study visit, at the termination date, and at regular intervals following termination from the study visit, at the termination date. | — |
Countries
Belgium, Italy, Spain, United Kingdom
Outcome results
None listed