A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tr… (NCT02711553) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
United States309 participantsStarted 2016-05-19
Plain-language summary
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
* Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
* Have adequate biliary drainage.
* Have adequate organ function.
* Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method.
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose.
* Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations.
Exclusion Criteria:
* Previous systemic therapy for locally advanced or metastatic disease is not allowed.
* Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade \>1, or cirrhosis with Child-Pugh Stage B or higher.
* Have ongoing or recent (≤6 months) hepatorenal syndrome.
* Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization.
* Anticipate having a major surgical procedure during the course of the study.
* …
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)