NCT00036036

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

October 17, 2011

Status Verified

October 1, 2011

First QC Date

May 7, 2002

Last Update Submit

October 14, 2011

Conditions

Renal Cell Carcinoma

Keywords

renalrenal cell cancerrenal cell carcinomakidney cancer

Interventions

CP-461DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Measurable metastatic or locally advanced disease.
  • Histologically confirmed renal cell cancer.
  • 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.
  • Expected remaining life span \> or = three months.
  • ECOG performance status 0-2.
  • \> or = 18 years of legal age.
  • Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
  • Negative serum pregnancy test, if fertile female.
  • Willingness and ability to sign an informed consent document.

You may not qualify if:

  • Uncontrolled or symptomatic brain metastases.
  • Use of an investigational medication or device within one month of initiating study therapy.
  • 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.
  • Any condition or any medication which may interfere with the conduct of the study.
  • Current active malignancy other than renal cell cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

(5-fluoro-2-methyl-1-(4-pyridyl)methylene-3-(N-benzyl)-indene)-acetamide hydrochloride

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2002

First Posted

May 8, 2002

Study Start

July 1, 2001

Study Completion

July 1, 2003

Last Updated

October 17, 2011

Record last verified: 2011-10

Locations

US(1)