Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination with Cisplatin and Capecitabine as First-Line Therapy in Patients with Inoperable Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas - CA194-004

Bristol-Myers Squibb0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1) Signed Written Informed Consent
•2) Subjects with histologically or cytologically confirmed metastatic esophageal,gastric, or gastroesophageal adenocarcinoma.
•3) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•4) Estimated life expectancy of at least 3 months
•5) Biopsies - Subjects in the dose escalation portion of the study will have one pre-treatment biopsy. Subjects in the dose expansion portion of the study will have one pre-treatment biopsy and two on-treatment for biomarker and predictive marker analyses.
•6) No prior chemotherapy for the target disease is permitted.
•7) Men and women, ages 18 and above.
•8) WOCBP must have a negative serum or urine pregnancy test

•1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the last dose of investigational product.
•2) Sexually active fertile men not using effective birth control while on study and for at least 3 months following treatment with BMS-833923.
•3) Subjects with known symptomatic brain metastasis.
•4) Any serious, uncontrolled medical disorder or acute infection which would impair the ability of the subject to receive protocol therapy.
•5) Any gastrointestinal surgery, unresolved bowel obstruction or malabsorption syndrome that could impact the absorption of study drug.
•6) Uncontrolled or significant cardiovascular disease.
•7) Active or chronic infection with HIV, HepB, or HepC.
•8) Positive Pregnancy Test

发起方

Bristol-Myers Squibb