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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00372853
First received: September 5, 2006
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Carcinoma, Renal Cell
 Drug: CP-675,206
Drug: SU011248
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 [ Time Frame: 6 weeks after first dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • To monitor for an antibody response to CP-675,206 [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • To assess any preliminary evidence of anti-tumor activity: 6-18 months after last subject enrolled [ Time Frame: 6-18 months after last subject enrolled ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372853

Locations
United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85258
United States, New Jersey
Research Site
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00372853     History of Changes
Other Study ID Numbers: A3671025
Study First Received: September 5, 2006
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

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
 Sunitinib
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors

ClinicalTrials.gov processed this record on June 13, 2013