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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine


The aim of this study is to determine if paclitaxel given together with ramucirumab as
second line therapy will prolong overall survival compared to paclitaxel alone.

Approximately 663 patients (at least 18 years) in approximately 200 study centers and in
approximately 30 countries will be randomized with histologically or cytologically confirmed
metastatic gastric or gastroesophageal junction adenocarcinoma. Patients must have received
at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with
or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy
prior to study entry due to disease progression.

Upon registration and completion of screening procedure and reviewing the Inclusion and
Exclusion Criteria eligible patients will be randomized to receive either paclitaxel plus
ramucirumab or paclitaxel plus placebo.

Ramucirumab DP/placebo will be administered i.v. on days 1 and 15 , paclitaxel will be
administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.

Patients will be continuously treated and monitored until radiographic or symptomatic
progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal
of consent.


Inclusion Criteria:



- Signed informed consent

- histologically or cytologically confirmed gastric or gastroesophageal junction
adenocarcinoma

- Metastatic disease or locally advanced, unresectable disease

- Disease progression during or within 4 months after the last dose of the first-line
therapy (platinum/fluoropyrimidine doublet with or without anthracycline)

- Organs are functioning well (liver, kidney, blood)

- Good performance status (ECOG 0 to 1)

Exclusion Criteria:

- First line chemotherapy for metastatic gastric cancer other than
platinum/fluoropyrimidine doublet with or without anthracycline

- Previous systemic therapy with other anti-angiogenic drugs

- Uncontrolled high blood pressure

- Symptomatic or poorly controlled heart disease or had a heart attack or stroke within
the last 6 month

- Evidence of CNS metastasis at baseline

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival time (OS)

Outcome Description:

Overall survival time is measured as randomization to date of death from any cause.

Outcome Time Frame:

Approximately 32 months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

Argentina: Ministry of Health

Study ID:

13894

NCT ID:

NCT01170663

Start Date:

December 2010

Completion Date:

September 2014

Related Keywords:

  • Gastric Cancer
  • Metastatic Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteVoorhees, New Jersey  08043
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteHonolulu, Hawaii  96813
ImClone Investigational SiteSeattle, Washington  98104
ImClone Investigational SiteAlbuquerque, New Mexico  87131