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Protocol # 15-287

Status

Recruiting

Description

The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment [ME2] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.

Condition

  • Hepatocellular Carcinoma

Interventions

  • Ramucirumab
  • Placebo

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Survival (OS)

Secondary Outcome:

  • Progression Free Survival (PFS)
  • Time to Radiographic Progression
  • Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
  • Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion
  • PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion
  • Percentage of Participants With Anti-Ramucirumab Antibodies
  • Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
  • Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
  • Time to Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Enrollment

292

Study Start Date

July 20, 2015

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Eli Lilly and Company

Source

Eli Lilly and Company

Official title

Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib

Clinicaltrials.gov Identifier

NCT02435433

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.