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Clinical Trial 19477

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT03686488

Phase: Phase II
Principal Investigator: Kim, Dae Won

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase II study of TAS 102 in Combination with Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary

This is a single institutional phase II single arm two-stage design trial using the combination of TAS 102 and ramucirumab in advanced, refractory gastric or GEJ adenocarcinoma.

Objective

Primary Objective To determine the 6 month overall survival in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma receiving TAS 102 in combination with ramucirumab. Secondary Objectives 1. To determine the frequency and severity of adverse events and tolerability of TAS 102 plus ramucirumab in patients with advanced, refractory gastric or GEJ adenocarcinoma 2. To determine the objective response rate of TAS 102 in combination with ramucirumab based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 3. To determine the progression free survival in patients with advanced, refractory gastric or GEJ adenocarcinoma receiving TAS 102 in combination with ramucirumab. Exploratory Objectives 1. To evaluate potential correlations between blood biomarkers and clinical outcome using a multiplex assay evaluating circulating angiogenic biomarkers

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

IMC-1121B (Ramucirumab); Ramucirumab (); TAS 102 ()

Inclusion Criteria

Histologically confirmed diagnosis of gastric and GEJ adenocarcinoma.

Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Stage IV or recurrent disease is required. An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation.

Participants must have received and progressed with prior therapy. Prior therapy with ramucirumab is not allowed. Participants must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia).

Adequate bone marrow, liver and renal function.

Participants must not have had chemotherapy,major surgery, monoclonal antibody therapy or experimental therapy within the 28 days prior to the start of TAS 102 administration.

Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.

Participants (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form until at least 4 months for both females and males after the last dose of study drug.

Participants must be able to understand and be willing to sign the written informed consent form.

Exclusion Criteria

Participants with active Central Nervous System (CNS) metastases are excluded. If CNS metastases are treated and participants are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment.

Women who are pregnant or breast-feeding.

Prior therapy with ramucirumab, bevacizumab, regorafenib or TAS 102.

Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder 15 tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].

Uncontrolled hypertension (systolic BP >140 mm Hg or diastolic BP >90 mm Hg on repeated measurement despite optimal medical management)

Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication, or any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.

Persistent proteinuria ≥ Grade 3 on repeated measurement

Participants with an arterial thrombotic or thromboembolic event within 12 months of informed consent.

Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 4 weeks

Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.

Clinically significant cardiovascular disease such as unstable angina, uncontrolled or symptomatic arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months prior to first dose with study drug.

Unable to swallow capsules or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease affecting the small intestine.

Child-Pugh B cirrhosis (or worse) or a history of hepatic encephalopathy

History of stroke or intracranial hemorrhage within 6 months prior to enrollment.

Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.

Major surgery or a wound that has not fully healed within 4 weeks of enrollment.

Patients who need anticancer chemotherapy other than the study drugs during the study or within 4 weeks of study enrollment.

Patients who need anti-cancer hormonal therapy during the study or within 2 weeks of first study enrollment.

Patients who need radiotherapy to target lesions during study or within 2 weeks of enrollment.

Patients who had bone marrow transplant or stem cell rescue.

Patients who need investigational drug therapy outside of this trial during or within 4 weeks of first study treatment.

Additional exclusions apply

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