MDACC Study Summary 2006-0818

Study Summary
No. 2006-0818:.......Melanoma......Wen-Jen Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2006-0818

Study Title:	A Rollover Protocol for Patients Who Received CP-675,206 in Other Protocols

Physician

New Patient Referral



Name:	Wen-Jen Hwu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4964 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Screening, within 10 days of the start of each cycle, and Day1 of each Cycle. Each Cycle is 90 days.

Treatment Agents:	CP-675-206	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to make it possible for patients who received CP-675,206 in other clinical studies to have access to CP-675,206 before it is available for sale in the patient's country. The ability of the drug to help control the disease, how well it is tolerated, and its safety will also be studied.

Study Objectives / Outcomes

Primary Objective:

To allow access to CP-675,206 for subjects who received CP-675,206 in other trials

Secondary Objectives:

To follow long-term survival and tumor status of subjects treated with CP-675,206 in other trials
To monitor the safety and tolerability of CP-675,206

Study Status Information



Study Activation / Registration Date:	03/05/2007

IRB Review and Approval Date:	12/06/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	2

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The subject received CP-675,206 in another protocol.

2) Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgment of the investigator.

3) Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures.

Exclusion Criteria:

1) There are no exclusion criteria.

Links

Registration Number: NCT00378482
Study Information on Clinical Trials Registry (clinicaltrials.gov)