Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Bile Duct Diseases

Gallbladder Diseases

Bile Duct Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Regorafenib

Richard Kim, M.D.

The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers

OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.

DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Spots Global Cancer Trial Database for Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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