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CompletedNCT00036036Updated Oct 17, 2011

Study of CP-461 in Patients With Advanced Renal Cell Cancer

A Phase 2 interventional study of CP-461 in Renal Cell Carcinoma, sponsored by Astellas Pharma Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-17.

Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.

02

Conditions studied

  • Renal Cell Carcinoma

Keywords

  • renal
  • renal cell cancer
  • renal cell carcinoma
  • kidney cancer
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 14 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Measurable metastatic or locally advanced disease.
  2. Histologically confirmed renal cell cancer.
  3. No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
  4. Expected remaining life span > or = three months.
  5. ECOG performance status 0-2.
  6. > or = 18 years of legal age.
  7. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
  8. Negative serum pregnancy test, if fertile female.
  9. Willingness and ability to sign an informed consent document.

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled or symptomatic brain metastases.
  2. Use of an investigational medication or device within one month of initiating study therapy.
  3. Absolute granulocyte count \< or = 1500/mm3; Platelet count \< or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN.
  4. Any condition or any medication which may interfere with the conduct of the study.
  5. Current active malignancy other than renal cell cancer.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants

Interventions

  • DrugCP-461
06

Study locations

1 site
  • UCLA Medical Center
    Los Angeles, California 90095, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00036036
Lead sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals
Responsible party
Sponsor
First posted
May 8, 2002
Start date
Jul 2001
Completion
Jul 2003
Last update
Oct 17, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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