Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:

A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389285
• Other study ID #: 494F01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 16, 2006
• Last updated: May 26, 2009
• Start date: October 2006
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: ZymoGenetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).

Description:

This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of RCC of predominantly clear cell histology

• Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)

• At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)

• Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)

Exclusion Criteria:

• Presence of acute infection or other significant systemic illness

• Central nervous system involvement by malignancy

• History of other cancer within 5 years

• Previously received rIL-21 or sorafenib

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• rIL-21 only
Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
• rIL-21 + sorafenib
Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Premiere Oncology of Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ZymoGenetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile, including incidence and severity of adverse events		During treatment and 28 days after last dose of rIL-21	Yes
Secondary	Objective response rate at recommended dose of rIL-21		Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached	No
Secondary	Progression-free survival at recommended dose of rIL-21		Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached	No
Secondary	Pharmacokinetic profiles of rIL-21 and sorafenib		rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing	No