Featured Clinical Trial:

Chemotherapy Induced Anemia in Non-Small Cell Lung Cancer (product/compound: ACE-011)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01284348.

Condition: Anemia

Product Name/Compound: ACE-011: 15 mg, 30 mg, and 45 mg

Full Study Title: A Single-blind, Randomized, Phase 2A, Dose Ranging Study (Part 1) of ACE-011 Therapy Followed by a Phase 2B/3, Double-blind, Randomized, Placebo-controlled Study (Part 2) of ACE-011 for Chemotherapy Induced Anemia (CIA) in Subjects With Metastatic Non-small Cell Lung Cancer (NSCLC) Treated With First-line Platinum-based Chemotherapeutic Regimens

Study Summary: The purpose of this study is to determine an effective and safe dose of ACE-011 for the treatment of chemotherapy induced anemia (CIA) in patients with metastatic non-small cell lung cancer who are being treated with first-line platinum based chemotherapy.

Eligible Participants:

Inclusion (Eligible):

1. Men and women >= 18 years of age
2. Histologically confirmed non-small cell cancer of the lung
3. Documented metastatic (Stage IV) disease
4. Measurable or non-measurable disease evaluable by Response Evaluation Criteria in Solid Tumors (RECIST)
5. All of the following laboratory values Hemoglobin >6.5 to <11.0 g/dL Absolute neutrophil count >500/mm3 Platelet count > 25,000/mm3 (>72 hours since prior platelet transfusion) Adequate renal function (creatinine <1.5 x upper limit normal or >50 mL/min) Hepatic function (bilirubin <1.5 x upper limit normal; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit normal and <5 upper limit normal for subjects with liver metastases) Corrected calcium within normal limits, previous hypercalcemia allowed
6. May have received up to 3 cycles of a current first line platinum based chemotherapy treatment regimen for metastatic non-small cell lung cancer. Allowed regimens are:
   Gemcitabine plus cisplatin or carboplatin + bevacizumab Pemetrexed plus cisplatin or carboplatin + bevacizumab Paclitaxel plus carboplatin + bevacizumab
7. >28 days since previous treatment with ESA
8. >14 days since last red blood cell transfusions
9. Eastern Oncology Cooperative Group (ECOG) Performance status 0-2
10. Stable dose of biphosphonate therapy for >2 months or if not currently on biphosphonates, no treatment within 2 months prior to Day 1
11. 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
12. Males must use latex condom or non-latex condom not made of (animal) membrane during any sexual contact with female of childbearing potential
13. Life expectancy of >3 months
14. Willing to adhere to study visit schedule
15. Understand and voluntarily sign informed consent

Exclusion (Not Eligible):

1. National Cancer Institute Common Terminology for Adverse Events Grade >3 toxicity
2. Prior radiation to >20% of whole skeleton
3. Prior regimen(s) of platinum based chemotherapy for metastatic non-small cell lung cancer
4. Central nervous system metastases
5. Clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic, or genitourinary disease unrelated to underlying non-small cell lung cancer
6. Classification of 3 or higher heart failure (as classified by New York Heart Association)
7. 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
8. Diagnosis of a myeloid malignancy or known history of myelodysplasia
9. History of second malignancy within 3 years
10. Recent history (within 14 days of Day 1) of IV/oral antibiotics due to post septic episode
11. Uncontrolled hypertension (systolic must be <160mmHg diastolic must be <100mmHG)
12. Known human immunodeficiency virus (HIV)
13. Known active hepatitis B or C antibody
14. Iron deficiency
15. History of anemia as a result of inherited hemoglobinopathy
16. History of anemia due to autoimmune or hereditary hemolysis or gastrointestinal bleeding
17. Urine protein/creatinine ratio >1.0
18. Received treatment with another investigational drug or device within 28 days
19. Any prior use of ACE-011
20. Pregnant or lactating females
21. History of severe or severe anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product
22. Major surgery within 30 days

Study Phase: Phase II and Phase III (What are Phases?)

To receive information and updates for this trial:
Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT01284348

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