A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:September 14, 2015
End Date:July 1, 2019

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Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second-Line Gastric or Gastroesophageal Junction Adenocarcinoma

The main purpose of this study is to evaluate the safety and feasibility of administering
higher doses of ramucirumab in participants with gastric cancer.


Inclusion Criteria:

- The participant has a histopathologically or cytologically confirmed diagnosis of
gastric or gastroesophageal junction (GEJ).

- The participant has documented disease progression during or within 4 months after the
last dose of first-line chemotherapy for metastatic disease, or during or within 6
months after the last dose of neoadjuvant or adjuvant therapy.

- The participant received combination chemotherapy prior to disease progression.

- Prior chemotherapy regimens must include a platinum and/or a fluoropyrimidine
component and must not include a taxane or antiangiogenic agent.

- The participant has metastatic disease or locally advanced disease that is measurable
or nonmeasurable, but is evaluable disease by radiological imaging per Response
Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

- The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1.

- The participant has adequate organ function, including:

- Total bilirubin 1.5 × the upper limit of institutional normal (ULN) and alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) 3 × ULN. If the liver
has tumor involvement, AST and ALT <5 × ULN are acceptable.

- Serum creatinine 1.5 × ULN or calculated creatinine clearance (per the
Cockcroft-Gault formula or equivalent and/or 24-hour urine collection) 60
milliliters/minute (mL/min).

- Urinary protein is <2+ on dipstick or routine urinalysis.

- Absolute neutrophil count 1.5 × 10^9/Liter (L), platelets 100 × 10^9/L, and
hemoglobin 9 g/deciliter (dL) (5.58 millimoles/Liter).

- International normalized ratio 1.5 × ULN or prothrombin time 5 seconds above ULN.

- Partial thromboplastin time 5 seconds above ULN.

- The participant has an estimated life expectancy of 12 weeks in the judgment of the
investigator.

- The participant, if female and of child-bearing potential, must have a negative serum
or urine pregnancy test within 7 days prior to randomization.

Exclusion Criteria:

- The participant has squamous cell or undifferentiated gastric cancer.

- The participant is receiving chronic therapy with any of the following within 7 days
prior to randomization:

- Nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen,
naproxen, or similar agents), or

- Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or
anagrelide). Aspirin use at doses up to 325 milligrams (mg)/day is permitted.

- The participant received radiotherapy within 14 days prior to randomization.

- The participant received >1 line of prior therapy for the treatment of locally
advanced and unresectable or metastatic gastric or GEJ (Siewert Types I-III)
adenocarcinoma.

- The participant received previous treatment with agents targeting the vascular
endothelial growth factor (VEGF)/VEGF receptor 2 signaling pathway.

- The participant has documented brain metastases, leptomeningeal disease, or
uncontrolled spinal cord compression.

- The participant experienced any arterial thromboembolic event, including myocardial
infarction, unstable angina, cerebrovascular accident, or transient ischemic attack,
within 6 months prior to randomization.

- The participant has symptomatic congestive heart failure (New York Heart Association
II-IV) or symptomatic or poorly controlled cardiac arrhythmia.

- The participant has uncontrolled hypertension, as defined in Common Terminology
Criteria for Adverse Events (CTCAE) Version 4.0, prior to initiating study treatment,
despite antihypertensive intervention.

- The participant underwent major surgery within 28 days prior to randomization or
central venous access device placement within 7 days prior to randomization.

- The participant has a history of gastrointestinal perforation or fistula within 6
months prior to randomization.

- The participant has any condition (for example, psychological, geographical, or
medical) that does not permit compliance with the study and follow-up procedures or
suggests that the participant is, in the investigator's opinion, not an appropriate
candidate for the study.
We found this trial at
6
sites
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Jimmy Hwang
Phone: 980-442-6165
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Charlotte, NC
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Buenos Aires,
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Jaffer Ajani
Phone: 713-745-6754
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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1441 Eastlake Avenue
Los Angeles, California 90033
Principal Investigator: Syma Iqbal
Phone: 323-865-3900
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from
Los Angeles, CA
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Tucson, Arizona 85712
Principal Investigator: Manuel Modiano
Phone: 520-290-2510
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Tucson, AZ
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Tulsa, Oklahoma 74146
Principal Investigator: Scott Cole
Phone: 918-505-3200
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Tulsa, OK
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