MDACC Study Summary 2012-0534

Study Summary
No. 2012-0534:.......Leukemia......Srdan Verstovsek......Leukemia

Study Summary Title



Study Summary Number:	2012-0534

Study Title:	A PHASE-2, PROSPECTIVE, OPEN-LABEL STUDY TO DETERMINE THE SAFETY AND EFFICACY OF SOTATERCEPT (ACE-011) IN SUBJECTS WITH MYELOPROLIFERATIVE NEOPLASM (MPN) -ASSOCIATED MYELOFIBROSIS AND ANEMIA

Physician

New Patient Referral



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

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

Phone:	713-792-7305 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Sotatercept – ACE-011	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if sotatercept can help to control MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied.

Study Objectives / Outcomes

Determine safety and efficacy of sotatercept as therapy for persons with MPN-associated myelofibrosis and anemia

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/21/2013

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

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) MPN-associated myelofibrosis

2) Anemic patient OR RBC-transfusion-dependent patient

3) Equal to or greater than 18 years of age

4) ALT (SGPT) and AST (SGOT) equal to or less than 2.5x upper limit of normal (ULN), or equal to or less than 4x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF)

5) Direct bilirubin equal to or less than 1.5 x ULN; or equal to or less than 2x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis related to MF)

6) Serum creatinine equal to or less than 2.5 mg/dL

7) Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1

8) Women of childbearing potential and men must agree to using medically approved (i.e., mechanical or pharmacological) contraceptive measure for at least 112 days following the last dose of sotatercept (ACE-011), Males must agree to use a latex condom or non-latex condom NOT made of natural (animal) membrane during any sexual contact with females of childbearing potential or a pregnant female while participating in the study and for at least 112 days following the last dose of sotatercept (ACE-011), even if he has a vasectomy.

Exclusion Criteria:

1) Serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

2) Pregnant or lactating female

3) Known human immunodeficiency virus-1 (HIV-1), or hepatitis-B or -C

4) Use of any MPN-associated myelofibrosis-directed therapy within 4 weeks prior to study Day 1

5) Symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia

6) Uncontrolled hypertension. If hypertension is considered clinically stable, SBP must be <150 mmHg and DBP must be <100 mmHg

7) Prior sotatercept

8) Major surgery within 4 weeks prior to Day 1

9) Severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product

10) Any patient who is being treated for hypertension

Links

Registration Number: NCT01712308
Study Information on Clinical Trials Registry (clinicaltrials.gov)