Lung Cancer Clinical Trial
To Determine Safe and Effective Dose of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Advanced Non-small Cell Lung Cancer
The purpose of this study was to determine an effective and safe dose of ACE-011 for the treatment of chemotherapy induced anemia (CIA) in participants with metastatic non-small cell lung cancer who are being treated with first-line platinum based chemotherapy.
The ACE-011-NSCL-001 Phase 2a study was an open-label, randomized, dose-ranging study designed to assess the efficacy, safety, tolerability, pharmacokinetic and quality of life of sotatercept (ACE-011) for treatment of CIA in participants with advanced or metastatic solid tumors treated with platinum-based chemotherapeutic regimens. Other objectives included the effect of sotatercept treatment on bone metabolism, the evaluation of the expression of Activin A and other proteins/biomarkers (including myostatin and follistatin) and the assessment of renal function biomarkers. The study consisted of a Screening Period, a Treatment Period of approximately 6 months (up to 4 doses of sotatercept at either 15 mg or 30 mg administered subcutaneously every 42 days) and a Post-treatment Follow-up Period or End of Treatment (42 days after the last dose of sotatercept). The study was terminated early due to a slower than expected rate of enrollment as a result of substantial changes in the standard of care for cancer participants with anemia which resulted in challenges to timely accrual and completion of the study. Therefore, 26 participants were randomized into the study and the planned Part 2 of the study consisting of a double-blind, randomized, placebo-controlled Phase 2b/3 study conducted at the optimal dose of sotatercept (ACE-011) in up to 750 subjects with metastatic NSCLC was not performed. Due to the small sample size and variability of the data, changes were made to modify the study endpoints and revise them to be exploratory only.
Men and women > 18 years of age
Part 1: Histologically confirmed (cytology or biopsy) solid tumor malignancy, excluding those solid tumors treated with curative intent.
Part 2: Histologically confirmed non-small cell lung cancer
Documented metastatic disease
Measurable or non-measurable disease evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
All of the following laboratory values:
Hemoglobin ≥ 6.5 to < 11.0 g/dL (≥ 65 to < 110 g/L), due to chemotherapy-induced anemia
Absolute neutrophil count ≥ 500/mm^3
Platelet count ≥ 75,000/mm^3 (> 72 hours since prior platelet transfusion
Adequate renal function
creatinine clearance ≥ 40mL/min or ≥ 50 mL/min if cisplatin is concomitantly administered and
urine protein / creatinine ratio ≤ 1.0; or ≤ 2.0 if bevacizumab (Avastin®) is concomitantly administered
Hepatic function (bilirubin < 1.5 x upper limits of normal (ULN); AST and ALT < 3.0 x ULN and ≤ 5.0 ULN for subjects with liver metastases)
Subjects must have received:
at least one cycle and up to 4 cycles (q3w schedule) of platinum-based chemotherapy and be randomized prior to receiving Cycle 5 OR
at least one cycle and up to 3 months (depending upon regimen) of platinum-based chemotherapy
>28 days since previous treatment with ESA
>14 days since last red blood cell transfusions
Eastern Oncology Cooperative Group (ECOG) Performance status 0-2
For females of childbearing potential, highly effective method of birth control for at least 28 days before starting study, during participation and at least 112 days following last dose of ACE-011
Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential
Life expectancy of >3 months
Willing to adhere to study visit schedule
Understand and voluntarily sign informed consent
Part 2 only, history of prior regimen(s)of platinum-based chemotherapy for metastatic NSCLC and/or history of adjuvant platinum-based chemotherapy with last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic NSCLC.
National Cancer Institute Common Terminology for Adverse Events Grade >3 toxicity
Prior radiation to >20% of whole skeleton
Prior regimen(s) of platinum based chemotherapy for metastatic disease and/or history of adjuvant platinum-based chemotherapy with the last dose received less than six months prior to the start of current first-line platinum-based chemotherapy for metastatic disease
Central nervous system metastases
Clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic, or genitourinary disease unrelated to underlying malignancy
Classification of 3 or higher heart failure (as classified by New York Heart Association)
History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke, if not stable on anticoagulants and/or one of these events occurring in past 6 months
Diagnosis of a myeloid malignancy or known history of myelodysplasia
Recent history (within 14 days of Day 1) of IV/oral antibiotics due to post septic episode
Uncontrolled hypertension. Controlled hypertension is considered clinically stable, and systolic blood pressure (SBP) must be < 150 mmHg and diastolic blood pressure (DBP) must be < 100 mmHg.
Known human immunodeficiency virus (HIV)
Known active hepatitis B or C antibody
History of anemia as a result of inherited hemoglobinopathy
History of anemia due to autoimmune or hereditary hemolysis or gastrointestinal bleeding
Received treatment with another investigational drug or device within 28 days prior to Day 1, or if the half life of the previous product is known, within 5 times the half life prior to dosing, whichever may be longer.
Any prior use of Sotatercept (ACE-011).
Pregnant or lactating females or females planning to become pregnant
History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product (Refer to the Investigator's Brochure for further information).
Major surgery within 30 days prior to Day 1 (subjects must have completely recovered from any previous surgery prior to Day 1).
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There is 1 Location for this study
Phoenix Arizona, 85016, United States
Anaheim California, 92801, United States
Bakersfield California, 93309, United States
Fountain Valley California, 92708, United States
Fullerton California, 92835, United States
Loma Linda California, 92354, United States
Los Angeles California, 90095, United States
Mission Hills California, 91345, United States
Orange California, 92808, United States
Redondo Beach California, 90277, United States
Santa Maria California, 93454, United States
Stockton California, 95204, United States
Grand Junction Colorado, 81501, United States
Stamford Connecticut, 06902, United States
Ocala Florida, 34474, United States
Joliet Illinois, 60435, United States
Quincy Illinois, 62301, United States
Cedar Rapids Iowa, 52402, United States
Paducah Kentucky, 42001, United States
Burlington Massachusetts, 01805, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55404, United States
Billings Montana, 59102, United States
Henderson Nevada, 89014, United States
Lebanon New Hampshire, 03756, United States
Lake Success New York, 11042, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45267, United States
Bend Oregon, 97701, United States
Eugene Oregon, 97401, United States
Greenville South Carolina, 29605, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37232, United States
Bedford Texas, 76022, United States
Dallas Texas, 75201, United States
Galveston Texas, 77555, United States
Midland Texas, 79701, United States
Salem Virginia, 24073, United States
Tacoma Washington, 98405, United States
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