Study Condition(s): Advanced Cancer, Gastroesophageal Junction Cancer (GEJ), Liver Cancer, Non-small Cell Lung Cancer, Kidney Cancer, Stomach Cancer, Esophageal Cancer

A Study of LY2875358 in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer

Study Alias: JTBF

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02082210 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

The purpose of this study is to find a recommended schedule and dose range for LY2875358 when given with ramucirumab that may be safely given to participants with cancer. In Part A of this study, escalating doses of LY2875358 will be given in combination with a fixed dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose range of LY2875358 and ramucirumab has been established, Part B of the study will confirm safety and to see how well certain tumors respond to the combination of study drugs.

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18+ years

Time Commitment

The duration of your participation depends on how well your disease responds to the study treatment and how many cycles of treatment you receive.
  • Participant must have a confirmed diagnosis of one of the following tumor types that is advanced and/or metastatic cancer and is confirmed by histology or cytology
    • Part A: Any type of solid tumor
    • Part B1: stomach or Gastroesophageal Junction (GEJ) adenocarcinoma
    • Part B2: Liver cancer (excluding fibrolamellar carcinoma)
    • Part B3: Renal cell cancer
    • Part B4: Non-small cell lung cancer (squamous or non-squamous)
  • Participant must provide a tumor sample taken after progression on the most recent line of systemic tumor therapy or be willing to undergo a tumor biopsy prior to study treatment
  • Participant must have discontinued all previous cancer therapies and any agents that have not received regulatory approval and recovered from the acute effects of therapy, for at least 21 days prior to study enrollment
  • Participant of reproductive potential must agree to use medically approved contraceptive precautions during the study and for at least 3 months following the last dose of study drug
  • Female participant of childbearing potential must not be pregnant, have a negative serum pregnancy test 7 days before the first dose of study drug and must not be breast-feeding
  • Participant must not have a history of dangerously high blood pressure, headache, convulsions, or coma related to high blood pressure or poorly controlled hypertension despite standard medical management
  • Participant must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolic event during the 3 months prior to receiving study drugs
  • Participant must not have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to receiving study drugs
  • Participant must not have a known active fungal, bacterial, and/or known viral infection Participant must not have liver cirrhosis with a Child-Pugh Stage of B or C

Where to Participate

5 locations are currently available of 5 planned
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