Non small cell lung cancer. MedDRA version: 9.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS MedDRA version: 9.1 Level: LLT Classification code 10029515 Term: Non-small cell lung cancer recurrent MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic MedDRA version: 9.1 Level: LLT Classification code 10029516 Term: Non-small cell lung cancer stage 0 MedDRA version: 9.1 Level: LLT Classification code 10029517 Te
Conditions
Interventions
Product Name: ABT-869
Product Code: ABT-869, A-741439.0
Pharmaceutical Form: Tablet
CAS Number: 796967-16-3
Current Sponsor code: ABT-869, A-741439.0
Other descriptive name: 1-[4-(3-Amino-1H-indazol-4
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must be = 18 years of age. 2. The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non- squamous to be eligible. 3. The subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent. 4. The subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only). 5. The subject has an ECOG Performance Score of 0-1. 6. The subject must have adequate bone marrow, renal and hepatic function. Please refer to section 5.2.1 of the study protocol for further information. 7. Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to two months following completion of therapy. ? Total abstinence from sexual intercourse (minimum one complete menstrual cycle); ? A vasectomized partner; ? Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; ? Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream). Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. 8. The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). 2. The subject has received any anti-cancer therapy for treatment of NSCLC including investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or cytotoxic chemotherapy (i.e., alkalating agents, microtubule inhibitors, antimetabolites). 3. Subject has received radiation therapy within 21 days of Study Day 1. 4. The subject has had major surgery within 21 days. 5. The subject has untreated brain or meningeal metastases. CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, providing that they are asymptomatic, and do not require corticosteroids (must have discontinued steroids at least 1 week prior to study drug administration). 6. The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Warfarin®) for catheter prophylaxis will be permitted. 7. The subject has a central thoracic tumor lesion as defined by location within the hilar structures. The presence of central nodal disease is allowed. 8. The subject has proteinuria CTC Grade > 1 at baseline as measured by a UPC ratio of > 1 and confirmed by a 24-hour urine collection. 9. The subject has a history of, or currently exhibits clinically significant cancer related events of bleeding (e.g., gross hemoptysis defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode within 3 months prior to randomization unless definitively treated with surgery or radiation), or the subject has a recent history of (within 4 weeks of Study Day 1), or currently exhibits other clinically significant signs of bleeding. 10. The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg. Subjects may be re-screened if BP is shown to be controlled with or without intervention. 11. The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1. 12. The subject has a documented left ventricular (LV) ejection fraction < 50%. 13. The subject has known autoimmune disease with renal involvement (i.e., lupus). 14. The subject is receiving combination anti-retroviral therapy for HIV. 15. The subject has clinically significant uncontrolled condition(s) including but not limited to: ? Active uncontrolled infection; ? Symptomatic congestive heart failure; ? Unstable angina pectoris or cardiac arrhythmia; ? History of adrenal insufficiency; or ? Psychiatric illness/social situation that would limit compliance with study requirements. 16. The subject has a history of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin. Questions regarding inclusion of individual subjects should be directed to the Abbott Medical Monitor. 17. The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption. 18. The subject has a medical conditi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if the addition of oral ABT-869 to carboplatin and paclitaxel can prolong progression-free survival (PFS) compared to carboplatin and paclitaxel alone in subjects with NSCLC.;Secondary Objective: To evaluate overall survival and other efficacy endpoints as well as the safety and tolerability of each of the treatment arms. To evaluate Quality of Life (QoL), performance status and body weight.;Primary end point(s): The primary endpoint of the study is progression-free survival (PFS). The secondary endpoints of the study are overall survival, 12-month survival rate, time to disease progression (TTP), objective response rate, best response rate, best percent change in tumor size, duration of response as well as the safety and tolerability of the combination. The tertiary endpoints are QoL, performance status and body weight. | — |
Countries
Czech Republic
Outcome results
None listed