Dose-Finding Study Of CP-675,206 And SU011248 In Patients With Metastatic Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:

A Phase 1 Dose Escalation Trial To Evaluate The Safety And Tolerability Of CP-675,206 Administered In Combination With SU011248 To Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372853
• Other study ID #: A3671025
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2006
• Last updated: June 5, 2012
• Start date: November 2006
• Est. completion date: May 2010

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will determine the highest tolerable dose of CP-675,206 when given in combination with SU011248.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven renal cell carcinoma with metastases

• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1

Exclusion Criteria:

• Prior treatment with more than one systemic therapy for metastatic renal cell carcinoma

• History of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening Computed Axial Tomography (CT) or Magnetic Resonance Imaging (MRI) scan

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• CP-675,206
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
• SU011248
SU011248 administered at a dose of 37.5mg/day every day.
• CP-675,206
CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.
• SU011248
SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.

Locations

Country	Name	City	State
United States	Research Site	Cleveland	Ohio
United States	Research Site	Greenville	South Carolina
United States	Research Site	Memphis	Tennessee
United States	Research Site	New Brunswick	New Jersey
United States	Research Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the highest tolerable dose of CP-675,206 that can be combined with SU011248. The safety observation period will be 6 weeks from the first dose of study drug		6 weeks after first dose	Yes
Secondary	To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported		18 months	No
Secondary	To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination		up to 18 months	No
Secondary	To monitor for an antibody response to CP-675,206		up to 18 months	No
Secondary	To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled		6-18 months after last subject enrolled	No