A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Ramucirumab: Administered IV
Merestinib: Administered orally
Cisplatin: Administered IV
Gemcitabine: Administered IV
Placebo Oral: Administered orally
Placebo IV: Administered IV
Study 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.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)
PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Trial sites (82)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | |
| UCSF Medical Center at Mission Bay | San Francisco | California | |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | |
| University of Florida School of Medicine | Gainesville | Florida | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Washington University Medical School | City of Saint Peters | Missouri | |
| Washington University Medical School | Creve Coeur | Missouri | |
| Washington University Medical School | St Louis | Missouri | |
| Washington University Medical School | St Louis | Missouri | |
| Thomas Jefferson University | Philadelphia | Pennsylvania | |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | |
| Florida Cancer Specialists | Nashville | Tennessee | |
| Tennessee Oncology PLLC | Nashville | Tennessee | |
| Alexander Fleming | CABA | BS | |
| Hospital de Gastroenterologia Udaondo | Capital Federal | Buenos Aires | |
| Fundacion Ars Medica | San Salvador de Jujuy | Jujuy Province | |
| Clinica Viedma | Viedma | Río Negro Province | |
| Centro Medico San Roque | San Miguel de Tucumán | Tucumán Province | |
| Fundacion Favaloro | Ciudad de Buenos Aires | Argentina | |
| Fundación CORI para la Investigación y Prevención del Cáncer | La Rioja | Argentina | |
| Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan | San Juan | Argentina | |
| Calvary Mater Newcastle | Waratah | New South Wales | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Austin Health | Heidelberg | Victoria | |
| Landesklinikum Wr. Neustadt | Wiener Neustadt | Lower Austria | |
| Universitätsklinikum Salzburg | Salzburg | Austria | |
| KH der Barmherzigen Brüder Wien | Vienna | Austria | |
| Cliniques universitaires Saint-Luc | Brussels | Brussels Capital | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | |
| Masarykuv onkologicky ustav | Brno | Brno-město | |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | |
| Fakultni Nemocnice v Motole | Prague | Czechia | |
| Aarhus Universitetshospital, Aarhus Sygehus | Aarhus C | Denmark | |
| Odense Universitetshospital | Odense C | Denmark | |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | |
| CHU de Bordeaux Hop St ANDRE | Bordeaux | Gironde | |
| CHU de Besancon Hopital Jean Minjoz | Besançon | France | |
| Hôpital C. HURIEZ | Lille | France | |
| CHRU de Montpellier-Hopital St Eloi | Montpellier | France |
+ 42 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02711553 on ClinicalTrials.gov ↗ ← All trials in Mexico