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A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy


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

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Trial Information

A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy


Placebo-controlled, multicenter Phase 3 study of patients with metastatic gastric cancer
(including adenocarcinomas of the gastroesophageal junction) and disease progression on
standard first-line chemotherapeutic regimens. Patients will be randomized on a 2:1 basis
to receive best supportive care (BSC) plus IMC-1121B administered every 2 weeks or best
supportive care (BSC) plus placebo administered every 2 weeks, respectively. Patients will
undergo radiographic assessment of disease status every 6 weeks. Patients will be treated
until there is evidence of progressive disease (PD), toxicity requiring cessation,
withdrawal of consent, or until other withdrawal criteria are met.

Approximately 348 patients, with histologically- or cytologically-confirmed, metastatic
gastric or GEJ adenocarcinoma, and radiographically measurable disease as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable, nonmeasurable disease,
will be randomized. Patients will be enrolled from approximately 250 study centers in North
America, South America, Central America, Asia, Australia, New Zealand, and Europe.


Inclusion Criteria:



- Histologically or cytologically confirmed gastric carcinoma, including gastric
adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma

- Metastatic disease or locally recurrent, unresectable disease with measurable lymph
node metastases

- Measurable disease and/or evaluable disease. Measurable disease is defined as at
least one unidimensionally-measurable target lesion (≥ 2 cm with conventional
techniques or ≥ 1 cm by spiral CT), as defined by RECIST Examples of evaluable,
nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas
of known disease, or peritoneal nodules that are too small to be considered
measurable by RECIST

- Experienced disease progression during or within 4 months after the last dose of
first-line therapy for metastatic disease, or during or within 6 months after the
last dose of adjuvant therapy

- Disease is not amenable to potentially curative resection

- Patient is ≥ 18 years of age

- Patient has a life expectancy of ≥ 12 weeks

- Patient resolution to Grade ≤ 1 (or to Grade ≤ 2 in the case of neuropathy) by the
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE),
Version 3.0, of all clinically significant toxic effects of prior chemotherapy,
surgery, radiotherapy, or hormonal therapy (with the exception of alopecia)

- Eastern Cooperative Oncology Group Performance Status score of 0-1

- The patient has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL
(25.65 µmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0
x the upper limit of normal (ULN) [or 5.0 x the ULN in the setting of liver
metastases]

- The patient has adequate renal function as defined by a serum creatinine ≤ 1.5 x the
ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 40 mL/minute
(ie, if serum creatinine is > 1.5 x the ULN, a 24-hour urine collection to calculate
creatinine clearance must be performed)

- The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis ([UA]; if
urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein
must demonstrate < 1000 mg of protein in 24 hours to allow participation in the
study)

- The patient has adequate hematologic function, as evidenced by an absolute neutrophil
count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL

- The patient must have adequate coagulation function as defined by International
Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds
above the ULN (unless receiving anticoagulation therapy). Patients on
anticoagulation therapy with unresected primary tumors or local tumor recurrence
following resection are not eligible

- If the patient has received prior anthracycline therapy as part of his or her
first-line regimen, the patient is able to engage in ordinary physical activity
without significant fatigue or dyspnea

- Because the teratogenicity of IMC-1121B is not known, the patient, if sexually
active, must be postmenopausal, surgically sterile, or using effective contraception
(hormonal or barrier methods)

- Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to randomization

- Able to provide informed written consent and is amenable to compliance with protocol
schedules and testing

Exclusion Criteria:

- Documented and/or symptomatic brain or leptomeningeal metastases

- Experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to
randomization

- Experienced any arterial thromboembolic events, including but not limited to
myocardial infarction, transient ischemic attack, cerebrovascular accident, or
unstable angina, within 6 months prior to randomization

- Ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled
thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical
disorders in the opinion of the investigator

- Ongoing or active psychiatric illness or social situation that would limit compliance
with study requirements

- Uncontrolled or poorly-controlled hypertension despite standard medical management

- Patient has a serious or nonhealing wound, ulcer, or bone fracture

- Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric
cancer within 2 weeks prior to randomization

- Received any investigational therapy within 30 days prior to randomization

- Undergone major surgery within 28 days prior to randomization, or subcutaneous venous
access device placement within 7 days prior to randomization

- Received prior therapy with an agent that directly inhibits VEGF or VEGFR-2 activity
(including bevacizumab), or any antiangiogenic agent

- Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal
anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others),
dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose
325 mg/day) is permitted

- Patient has elective or planned major surgery to be performed during the course of
the clinical trial

- Patient has a known allergy to any of the treatment components

- Pregnant or lactating

- Known to be positive for infection with the human immunodeficiency virus

- Known alcohol or drug dependency

- Patient has a concurrent active malignancy other than adequately-treated
nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A
patient with previous history of malignancy is eligible, provided that he/she has
been free of disease for > 3 years

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival (OS)

Outcome Description:

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

Outcome Time Frame:

Approximately 30 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:

13893

NCT ID:

NCT00917384

Start Date:

October 2009

Completion Date:

September 2013

Related Keywords:

  • Gastric Cancer
  • Adenocarcinoma
  • IMC-1121B
  • Monoclonal antibody (MAb)
  • Vascular endothelial growth factor
  • VEGF
  • Human vascular endothelial growth factor receptor-2
  • VEGFR-2
  • Platinum resistant
  • platinum refractory
  • Gastric
  • Gastroesophageal Junction Adenocarcinoma
  • metastatic
  • Angiogenesis
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteBoston, Massachusetts  02135
ImClone Investigational SiteGrand Island, Nebraska  68803
ImClone Investigational SiteProvidence, Rhode Island  02903