Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers

Stopped early · Phase 2

Conditions studied: Upper GI Cancer

In brief

Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach

Key facts

Study ID

NCT02241720

Run by

University of Utah

People needed

5

Starts

2014-05-01

Expected to finish

2016-09-01

Last updated by the study team

2018-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of metastatic or locally advanced inoperable adenocarcinoma of the esophagus, gastroesophageal junction or stomach.
• Patients must show signs of progression during or less than 4 months after being treated with a first line therapy for their metastatic or locally advanced inoperable cancer.
• Patients must have measureable disease at screening by Response Evaluation Criteria for Solid Tumors 1.1 criteria
• Age greater than or equal to 18 years.
• Eastern Cooperative Oncology Group Performance Status 0-1
• Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
• All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 1 or less at the time of signing the Informed Consent Form. Alopecia (any grade) and peripheral neuropathy less than grade 2 is allowed.
• Adequate bone marrow, liver and liver function as assessed by laboratory requirement
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
• Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form until at least 3 months after the last dose of study drug. Highly effective contraception must be used (male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) by both sexes.
• Subject must be able to swallow and retain oral medication.

You may not qualify if…

• Prior use of regorafenib
• Uncontrolled hypertension (systolic pressure greater than 140 mm Hg or diastolic pressure greater than 90 mm Hg National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 on repeated measurement) despite optimal medical management.
• Active or clinically significant cardiac disease including:
• Congestive heart failure - New York Heart Association greater than Class 2.
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers.
• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event greater than or equal to National Cancer Institute Common Terminology Criteria for Adverse Events Grade 3 within 4 weeks prior to start of study medication.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
• Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to start of study treatment.
• Patients with severe hepatic impairment (Child-Pugh Class C)
• Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Patients requiring intravenous antiviral or intravenous antibiotic treatment for ongoing infections
• Symptomatic metastatic brain or meningeal tumors.
• Presence of a non-healing wound, non-healing skin ulcer, or bone fracture.
• Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample. If the result is normal then no additional testing is required. If the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is less than Grade 3.
• Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
• Pleural effusion or ascites that causes respiratory compromise (greater than or equal to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Grade 2 dyspnea). Patients may undergo thoracentesis and paracentesis to improve symptoms prior to enrollment.
• History of organ allograft (including corneal transplant).
• Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
• Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption.
• Women who are pregnant or breast-feeding.
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
• Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study results.
• Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 28 days of starting study treatment. Palliative radiation is allowed.

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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