Single Agent Regorafenib in Refractory Advanced Biliary Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02115542|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2014
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Bile Duct||Drug: Regorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers|
|Actual Study Start Date :||April 10, 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: Regorafenib Monotherapy
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.
- Overall Survival (OS) at 6 Months [ Time Frame: Post 6 months follow-up, up to 13 months from on treatment per participant ]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.
- Disease Control Response (DCR) [ Time Frame: Post 6 months follow-up, up to 13 months from on treatment per participant ]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.
- Progression Free Survival (PFS) [ Time Frame: Post 6 months follow-up, up to 13 months from on treatment per participant ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115542
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|UNC Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Virginia|
|VCU Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Richard Kim, M.D.||H. Lee Moffitt Cancer Center and Research Institute|