Clinical Trial: Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.



Original Secondary Outcome: Same as current

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: April 11, 2014
Date Started: April 10, 2014
Date Completion: October 2018
Last Updated: March 28, 2017
Last Verified: March 2017