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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00372853

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: CP-675,206 Drug: SU011248 Drug: CP-675,206 Drug: SU011248	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm A

Drug: CP-675,206

CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.

Drug: SU011248

SU011248 administered at a dose of 37.5mg/day every day.

Experimental: Arm B

Drug: CP-675,206

CP-675,206 administered intravenously every 3 months. Escalating doses from 6mg/kg to 15mg/kg will be tested.

Drug: SU011248

SU011248 administered at a dose of 50mg/day for 4 weeks followed by 2 weeks off, repeated every 6 weeks.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported [18 months]
To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination [up to 18 months]
To monitor for an antibody response to CP-675,206 [up to 18 months]
To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled [6-18 months after last subject enrolled]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Scottsdale	Arizona	United States	85258
2	Research Site	New Brunswick	New Jersey	United States	08903
3	Research Site	Cleveland	Ohio	United States	44195
4	Research Site	Greenville	South Carolina	United States	29605
5	Research Site	Memphis	Tennessee	United States	38120