Clinical trial comparing AXL1717 to docetaxel in patients with previously treated, locally advanced, or metastatic squamous cell carcinoma or adenocarcinoma of the lung

• Conditions: on-small-cell lung cancer previously treated; MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002007-15-HU
• Lead Sponsor: Axelar AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-11
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Be informed of the nature of the study and have provided written informed consent
2. At least 18 years of age
3. 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)
4. For patients with squamous cell histology: previously treated with first-line chemotherapy and has had disease progression during or after first-line therapy. Patients with SCC who have received more than one line of chemotherapy for NSCLC are not eligible.
5. For patients with adenocarcinoma histology: previously treated with one or two lines of chemotherapy. Use of switch maintenance such as maintenance with pemetrexed will be considered a line of therapy, while use of continuation maintenance such as maintenance with bevacizumab will not be considered a line of therapy. Patients with AC who have received more than two lines of chemotherapy for advanced NSCLC are not eligible.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 after optimization of analgesics
7. Life expectancy = 3 months, and patient expected to receive at least two cycles of therapy at the time of study enrollment
8. Measurable disease by RECIST 1.1 criteria
9.If a patient has had prior or recent radiation therapy:
a.Lesion(s) used for determination of RECIST response were not previously or recently irradiated or have documented an increase in size since the completion of the radiotherapy.
b.The patient has recovered from any acute effects of the radiotherapy prior to randomization
c.Radiotherapy is completed at least 14 days prior to the administration of study drug
10.Hematology values: blood leukocyte count = 3.0 x 10(9)/L, blood absolute neutrophil count = 1.5 x 10(9)/L, blood platelet count = 100 x10(9)/L, hemoglobin = 100 g/L (transfusions are allowed)
11. 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. 12-lead ECG with normal tracings; or changes that were not clinically significant and did not require medical intervention
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

1. Mixed histology of squamous and non-squamous NSCLC
2. Lung tumors assessed by the local radiologist as centrally located and/or involvement of any large blood vessels in the mediastinum.
3. Presence of any endo-bronchial lesions
4. Recent hemoptysis of = 1 tsf (tablespoon full ~ 15ml) within the past 14 days
5. Recent (within past 2 weeks) or current use of anticoagulation therapy or any known coagulopathy or bleeding diathesis. (Patients on anticoagulation therapy for a thromboembolic event should not stop anticoagulation therapy to become eligible for the trial.)
6. Ongoing infection or other major recent or ongoing disease that, according to the Investigator, poses an unacceptable risk to the patient
7. Known primary or secondary central nervous system malignancy. (Patients with symptoms suggestive of possible CNS metastasis such as headache, dizziness or focal neurological deficits should undergo CT or MRI of the brain to rule out CNSmetastasis. Patients who do not have CNS symptoms do not need a CT or MRI of the brain.)
8. Active or previously treated carcinomatous meningitis
9. Truly non-measurable disease by RECIST 1.1 criteria, such as patients with one or more of the following without any RECIST measurable disease:
a. Bone lesions
b. Ascites
c. Pleural or pericardial effusion
d. Lymphangitis cutis or pulmonis
e. Cystic lesions
10. Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to = grade 1 with optimal management of constipation.)
11. Active hepatitis B, active hepatitis C, or known HIV infection
12. Coexisting uncontrolled medical condition, including active cardiac disease (such as unstable angina, myocardial infarction within six months, or New York Heart Association Class III/IV congestive heart failure), and significant dementia
13. 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)
14. 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
15. Major surgical procedure within 4 weeks prior to randomization
16. More than one prior anti-tumor systemic therapy for advanced squamous NSCLC, and more than two prior lines of chemotherapy for advanced adneocarcinoma NSCLC
17. Previous use of docetaxel in any line of therapy
18. Women of child bearing potential (WOCBP) who do not consent to using acceptable methods of contraception (i.e. two of the following – oral contraception, barrier contraception, intrauterine device). For purposes of this study, WOCBP include any female who has experienced menarche, who has not undergone tubal ligation, and who is not postmenopausal. Post menopause is defined as: amenorrhea = 12 consecutive months without another cause.
19. Women who are breast-feeding or have a positive pregnancy test at screening
20. Men who are capable of fathering a child and do not agree to using acceptable methods of contraception (such as barrier contraception or abstinence) during the study and for at least six months after the last dose of study drug. Men are considered ca

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified