NCT00810394

Sorafenib in Treating Patients With Advanced Malignant Solid Tumors

Single Agent Sorafenib in Advanced Solid Tumors: Phase II Evaluation of Dose Re-Escalation Following a Dose Reduction (IST000375)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sorafenib 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. PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors.

Detailed description

OBJECTIVES: Primary * To evaluate the feasibility of re-escalating the dose of sorafenib tosylate in patients with advanced malignant solid tumors who initially required a dose reduction for toxicity, and dose escalation in those patients who are able to tolerate the initial dose. Secondary * To evaluate the efficacy of this drug in these patients who are able to tolerate a dose escalation initially or after a dose reduction compared to those who are unable to tolerate a dose escalation. Tertiary * To evaluate the percentage and demographic characteristics of patients who are able to tolerate 2 dose escalations without a dose reduction. OUTLINE: This is a dose-finding study. * Course 1: Patients receive oral sorafenib tosylate twice daily at dose level 0 on weeks 1-4. * Course 2: Patients experiencing no dose-limiting or intolerable toxicities receive oral sorafenib tosylate at dose level +1 twice daily on weeks 5-8; while patients experiencing dose-limiting or intolerable toxicities receive oral sorafenib tosylate at dose level -1 once daily on weeks 5-8. * Course 3: Depending on whether or not patients are experiencing dose-limiting or intolerable toxicities, they are escalated to dose level 0 or dose level +2 (patients in both dose levels receive oral sorafenib tosylate twice daily) in weeks 9-12, or de-escalated to dose level 0 or dose level -2 (patients in dose level -2 receives oral sorafenib tosylate once every other day) in weeks 9-12. * Maintenance therapy: Patients receive oral sorafenib tosylate at the dose level\* attained at the end of course 3. Treatment continues in the absence of unacceptable toxicity. * Dose level de-escalation for toxicity or dose re-escalation after a toxicity-related dose reduction allowed to a maximum level of the initial dose level of the maintenance therapy. After completion of study therapy, patients are followed for up to 1 year.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	Sorafenib	Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable.

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-10-01
• Completion: 2012-03-01
• First posted: 2008-12-18
• Last updated: 2018-01-10
• Results posted: 2017-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study