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Completed

NCT Number: NCT00372853

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

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

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-675,206

Drug

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

SU011248

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To allow for the possibility of genotyping should an unexpected outcome or an increase in unexplained adverse events be reported

    Time frame: 18 months

  2. To evaluate the pharmacokinetics (PK) of CP-675,206 and SU011248 when given in combination

    Time frame: up to 18 months

  3. To monitor for an antibody response to CP-675,206

    Time frame: up to 18 months

  4. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2006
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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