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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare effectiveness and safety of experimental anticancer medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma of the lung.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axelar AB
• Treatments: Docetaxel

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