Study of Sotatercept (ACE-011) in Subjects With Myeloproliferative Neoplasm (MPN)-Associated Myelofibrosis (MF) and Anemia
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01712308
First received: October 18, 2012
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: Sotatercept |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Anemia Response [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]Primary analysis of response for each dose cohort performed once all 20 patients have been accrued to that dose cohort and treated for at least 5 cycles. Clinical efficacy assessed as anemia response with a target rate of greater than or equal to 30% at either dose level. Anemia response is a composite endpoint defined as an increase in hemoglobin in a subject with anemia or becoming RBC-transfusion-independent in a subject who is RBC-transfusion-dependent.
Secondary Outcome Measures:
- Duration of Response [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]Duration of response defined as date at which subject's objective status is first noted to be a response, to date progression is documented (if one has occurred) or to date of last follow-up (for those subjects who have not progressed).
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sotatercept (higer dose)
Patients treated with 0.5 mg/kg dose subcutaneously on Day 1 every 3 weeks.
|
Drug: Sotatercept
Higher dose group: 0.5 mg/kg dose subcutaneously on Day 1 every 3 weeks. Lower dose group: 0.3 mg/kg dose subcutaneously on Day 1 every 3 weeks. Other Name: ACE-011
|
|
Experimental: Sotatercept (lower dose)
Patients treated with 0.3 mg/kg dose subcutaneously on Day 1 every 3 weeks.
|
Drug: Sotatercept
Higher dose group: 0.5 mg/kg dose subcutaneously on Day 1 every 3 weeks. Lower dose group: 0.3 mg/kg dose subcutaneously on Day 1 every 3 weeks. Other Name: ACE-011
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- MPN-associated myelofibrosis
- Anemic patient OR RBC-transfusion-dependent patient
- Equal to or greater than 18 years of age
- 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)
- 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)
- Serum creatinine equal to or less than 2.5 mg/dL
- Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1
- 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:
- 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
- Pregnant or lactating female
- Known human immunodeficiency virus-1 (HIV-1), or hepatitis-B or -C
- Use of any MPN-associated myelofibrosis-directed therapy within 4 weeks prior to study Day 1
- Symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia
- Uncontrolled hypertension. If hypertension is considered clinically stable, SBP must be <150 mmHg and DBP must be <100 mmHg
- Prior sotatercept
- Major surgery within 4 weeks prior to Day 1
- Severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product
- Any patient who is being treated for hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712308
Contacts
| Contact: Srdan Verstovsek, MD | 713-792-7305 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Srdan Verstovsek, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01712308 History of Changes |
| Other Study ID Numbers: | 2012-0534 |
| Study First Received: | October 18, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia Myeloproliferative Neoplasm MPN Associated Myelofibrosis |
Anemia Sotatercept ACE-011 |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Anemia Neoplasms Leukemia |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013