MDACC Study Summary 2005-0222

Study Summary
No. 2005-0222:.......Endocrine......Camilo Jimenez......Endocrine Neoplasia & Hormonal Disorders

Study Summary Title



Study Summary Number:	2005-0222

Study Title:	ACROSTUDY – A Multicenter, Post Marketing Surveillance Study of Somavert Therapy in Patients with Acromegaly in the US and Europe

Physician

New Patient Referral



Name:	Camilo Jimenez	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Endocrine Neoplasia & Hormonal Disorders	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2840 Contact us about clinical trials

General Information



Disease Group:	Endocrine	Supported By:	N/A

Phase of Study:	Phase IV	Return Visit:	Will be Standard of Care -every 2-3 months until response established (IGF-1 normalizes) and then every 6 months

Treatment Agents:	Pegvisomat	Home Care:	Somavert is administered by the patient daily as a subcutaneous injection.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to look at the safety and effectiveness of long-term pegvisomant treatment for acromegaly.

Study Objectives / Outcomes

Primary objective: monitor the long-term safety of Somavert (Pegvisomant) as prescribed in clinical practice.

Secondary objective: collect a panel of parameters associated with efficacy and the ability of biochemical normalization.

Study Status Information



Study Activation / Registration Date:	09/15/2005

IRB Review and Approval Date:	08/17/2005

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	>1000

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 patient must have a diagnosis of acromegaly.

2) The patient must already be treated with Somavert or plan to start Somavert therapy.

3) Patients over the age of 18.

4) The patient must have had a pituitary imaging study performed within 6 months prior to the initiation of Somavert therapy or the start of ACROSTUDY (if the patient is already on Somavert treatment).

Exclusion Criteria:

1) Patients who require surgery to decompress the tumor or who should have non- medical therapy because of visual field loss, ( for example patients with the tumor in contact with the optic chiasm) cranial nerve palsies or intracranial hypertension.

2) Patients participating in any clinical trial on an investigational drug for acromegaly.

3) Patients (or legally acceptable representatives) who are unable to understand the nature of the study and are unwilling to sign an informed consent

4) Patients with allergies to Somavert or its ingredients

5) Patients who do not have a diagnosis of acromegaly.

6) Women who are pregnant or lactating.

7) Patients who have not had a pituitary imaging study within 6months of starting Somavert or enrolling into ACROSTUDY.

Links

Registration Number: Not Applicable Clinical Trial