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

This study has been completed.
Sponsor:
Information provided by:
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00389285
First received: October 16, 2006
Last updated: May 26, 2009
Last verified: May 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Carcinoma, Renal Cell
 Drug: rIL-21 only
Drug: rIL-21 + sorafenib
 Phase 1
Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:
  • Safety profile, including incidence and severity of adverse events [ Time Frame: During treatment and 28 days after last dose of rIL-21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate at recommended dose of rIL-21 [ Time Frame: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached ] [ Designated as safety issue: No ]
  • Progression-free survival at recommended dose of rIL-21 [ Time Frame: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached ] [ Designated as safety issue: No ]
  • Pharmacokinetic profiles of rIL-21 and sorafenib [ Time Frame: rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rIL-21 only
    Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
    Drug: 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)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389285

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
ZymoGenetics
Investigators
Study Director: Naomi Hunder, MD ZymoGenetics
  More Information

No publications provided

Responsible Party: Naomi Hunder, Medical Monitor, ZymoGenetics, Inc.
ClinicalTrials.gov Identifier: NCT00389285     History of Changes
Other Study ID Numbers: 494F01
Study First Received: October 16, 2006
Last Updated: May 26, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ZymoGenetics:
Carcinoma, renal cell
interleukin-21
sorafenib
Immunotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013