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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2003-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CP-461

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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OSI-461-003

Identifier Type: -

Identifier Source: org_study_id