Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers

NCT02241720 | Terminated Phase 2 Results DMC

• 1 other identifier: HCI68135
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Upper GI Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Stable Disease at Eight Weeks Post-Treatment

  Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  5 months - 3 months treatment and 8 weeks post end of treatment visit

Study Arms (1)

Regorafenib treatment

EXPERIMENTAL

Drug: regorafenib

Interventions

regorafenib DRUG

Regorafenib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Kimberlee Taylor
• Organization: Huntsman Cancer Institute

Kimberlee.Taylor@hci.utah.edu

801-213-5673

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: September 16, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 11, 2018
• Results First Posted: October 26, 2017

Record last verified: 2017-12

Locations

US (1)