A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Confirmed Response Rate
Study Overview
Brief Summary
This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in patients with advanced neuroendocrine tumors.
SECONDARY OBJECTIVES:
I. Adverse event rate(s). II. Progression free survival and time to progression. III. Improvement in circulating hormone levels. IV. Overall survival.
OUTLINE: This is a multicenter study. Patients are grouped into 2 separate analysis Groups according to tumor type (Group A: Carcinoid; Group B: Islet cell/other well-differentiated tumor). Each Group was independently evaluated for all study endpoints.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group A (patients with carcinoid tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
Intervention: sorafenib tosylate (Drug)
Group B (islet cell and other neuroendocrine tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
Intervention: sorafenib tosylate (Drug)
Outcomes
Primary Outcomes
Confirmed Response Rate
Time Frame: Duration of Treatment (Up to 2 years)
Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients.\> \> Complete Response (CR) is defined as the disappearance of all target lesions.\> Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions;\> \> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method.
Secondary Outcomes
- Progression Free Survival(Time from registration to progression or death (up to 2 years))
- Toxicity(Up to 2 years)
- Overall Survival(From registration to death (up to 2 years))
- Duration of Response(Time from response to progression (up to 2 years))