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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety profile, including incidence and severity of adverse events

Outcome Time Frame:

During treatment and 28 days after last dose of rIL-21

Safety Issue:

Yes

Principal Investigator

Naomi Hunder, MD

Investigator Role:

Study Director

Investigator Affiliation:

ZymoGenetics

Authority:

United States: Food and Drug Administration

Study ID:

494F01

NCT ID:

NCT00389285

Start Date:

October 2006

Completion Date:

May 2009

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma, renal cell
  • interleukin-21
  • sorafenib
  • Immunotherapy
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
University of Alabama Birmingham, Alabama  
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Premiere Oncology of Arizona Scottsdale, Arizona  85260