A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) plus Leucovorin (LV) in Subjects with Advanced Bilary Tumors Not Amenable to Coventional Surgery - XL119 versus 5-FU/LV in Advanced Biliary Tumors

Phase 1

• Conditions: Advanced Bilary Tract Tumours: Gall bladder cancer and Cholangiocarcinoma; MedDRA version: 7.0Level: LLTClassification code 10028982

• Registration Number: EUCTR2004-000327-15-ES
• Lead Sponsor: Exelixis, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-16
• Study Completion: 2006-11-29
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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 < 3·
5. Laboratory criteria (within 72 hours days of first treatment): white blood cell count (WBC) > 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 < 20,000/µL; normal blood urea nitrogen (BUN); serum creatinine; alanine transaminase (ALT) and aspartate transaminase (AST) within 2.5 times the upper limit of normal; bilirubin < 3 mg/dL·
6. Willing and able to sign informed consent·
7. Sexually active men and women must use an accepted and effective method of contraception·(including barrier contraception with spermicide)
8. Women of child-bearing age must have a negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified