Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung

Launched by AXELAR AB · Mar 21, 2012

Keywords

ClinConnect Summary

Non-Small-Cell lung Cancer (NSCLC) is the most common form of lung cancer, and treatment with cytotoxic chemotherapy only provides a 10% reduction in the risk of death in patients with advanced NSCLC. One-third of all non-resectable advanced NSCLC patients in second line do not receive chemotherapy treatment at all. In the absence of treatment the Progression-Free Survival (PFS) for NSCLC patients is dismal, in the range of 6-8 weeks, and treatment only modestly improves the median PFS to 10-11 weeks. Therefore, because of an overall poorer prognosis for patients with advanced NSCLC, develo...

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Eligibility criteria

• Inclusion Criteria:
• • informed of the study and have provided written informed consent
• • At least 18 years of age
• • Histologically confirmed diagnosis of locally advanced, or metastatic squamous cell carcinoma or adenocarcinoma histological subtypes of non-small-cell lung cancer (stage IIIB or IV)
• • For patients with squamous cell histology: previously treated with first-line chemotherapy and has had disease progression during or after first-line therapy.
• • For patients with adenocarcinoma histology: previously treated with one or two lines of chemotherapy.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• • Life expectancy ≥ 3 months
• • Measurable disease by RECIST 1.1 criteria
• • Hematology values: blood leukocyte count ≥ 3.0 x 109/L, blood absolute neutrophil count ≥ 1.5 x 109/L, blood platelet count ≥ 100 x109/L, hemoglobin ≥ 100 g/L (transfusions are allowed)
• • Clinical chemistry values: plasma total bilirubin level ≤ upper limit of the "normal" range (ULN; i.e. reference), plasma AST or ALT ≤ 1.5 x ULN (≤ 5 times if liver metastases have been documented) and plasma creatinine ≤ 2.0 x ULN
• • 12-lead ECG with normal tracings
• Exclusion Criteria:
• • Mixed histology of squamous and non-squamous NSCLC
• • Ongoing infection or other major recent or ongoing disease that, according to the Investigator, poses an unacceptable risk to the patient
• • Known primary or secondary central nervous system malignancy.
• • Active or previously treated carcinomatous meningitis
• * Truly non-measurable disease by RECIST 1.1 criteria, such as patients with one or more of the following without any RECIST measurable disease:
• • Bone lesions
• • Ascites
• • Pleural or pericardial effusion
• • Lymphangitis cutis or pulmonis
• • Cystic lesions
• • Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization.
• • Active hepatitis B, active hepatitis C, or known HIV infection
• • Coexisting uncontrolled medical condition, including active cardiac disease (such as unstable angina, myocardial infarction within 6 months, or New York Heart Association Class III/IV congestive heart failure), and significant dementia
• • Hepatic impairment as indicated by abnormalities of transaminases (AST and/or ALT \> 1.5 × ULN or AST and/or ALT \> 5 times ULN if liver metastases have been documented) and/or increased alkaline phosphatase (\> 2.5 × ULN) considered as a result of hepatic impairment (and not from bone disease)
• • History of cancer that has required treatment or been active within the past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ
• • Major surgical procedure within 4 weeks prior to randomization
• • More than one prior anti-tumor systemic therapy for advanced squamous cell NSCLC, and more than two prior lines of chemotherapy for advanced adenocarcinoma NSCLC
• • Previous use of docetaxel in any line of therapy
• • Women of child bearing potential (WOCBP) who do not consent to using acceptable methods of contraception
• • Women who are breast-feeding or have a positive pregnancy test at screening
• • Current participation in any other investigational clinical trial or any administration of an investigational agent within 4 weeks of study drug administration
• • ECOG performance status \> 2
• • Life expectancy \< 3 months
• • Known or suspected hypersensitivity to AXL1717 or docetaxel or to drugs formulated with polysorbate 80
• • Lack of suitability for participation in the trial, for any reason, as judged by the Investigator