None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with ZD6474 (presentation: in tablets), in doses of 300 mg, PO, QD until the objective progression of the disease, while in the opinion of the researcher they benefit from the treatment and do not fulfill any other criteria of withdrawal.
Group name:GROUP 2 Type of group
This group will be treated with ZD6474 Placebo (presentation: in tablets), PO, QD until the objective progression of the disease, while in the opinion of the researcher they benefit from the treatment and do not fulfill any other criteria of withdrawal.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Granting of informed consent. 2. Male or female from 18 years of age. 3. Histological or cytological confirmation of locally advanced or metastatic NSCLC upon entering the study. 4. Failure of previous treatment with an EGFR TKI. 5. WHO functional status 0-2. 6. Measurable disease according to RECIST. 7. Negative pregnancy test in women with reproductive potential. 8. Life expectancy of 12 weeks or more.
Exclusion criteria
Exclusion criteria: 1. Histology of small cell and non-small cell mixed lung cancer 2. Pre-treatment with VEGFR TKIs. 3. Chemotherapy or other treatment for systemic cancer within 4 weeks before the start of study medication. 4. Three or more previous chemotherapy regimens for advanced disease. 5. Last radiotherapy within 4 weeks before the start of the study medication. 6. Major surgery within the previous 4 weeks or surgical incision not completely healed before starting the study treatment. 7. Any toxicity grade CTCAE> 2 of previous treatment for cancer 8. Serum bilirubin> 1.5 x LSRR 9. Serum creatinine> 1.5 LSRR or creatinine clearance ≤ 50 ml / min. 10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2.5 x LSRR in the absence of liver metastases, or> 5 LSRR in the presence of liver metastases. 11. Alkaline phosphatase (FAL)> 2.5 x LSRR in the absence of liver metastases, or> 5 X LSRR in the presence of liver metastases. 12. Significant cardiovascular event, Classification of the New York Heart Association ≥ 2 within 3 months prior to admission. 13. History of arrhythmia that is symptomatic and requires treatment or sustained asymptomatic ventricular tachycardia. 14. Congenital or prolonged QT syndrome, 1st degree relative with sudden death of unknown cause before 40 years of age. 15. Prolongation of the QT by another medication, requiring the continuation of it. 16. Presence of left branch block. 17. QTc with Bazzet correction not measurable or> 480 msec or greater in the ECG of the selection. 18. Potassium <4.0 mmol / l despite supplementation; serum calcium, or magnesium outside the normal range despite supplementation. 19. Pregnant or breastfeeding women. 20. Any concomitant medication that may cause QTc prolongation or induce Torsades de Pointes or induce the function of CYP3A4. 21. Known or suspected brain metastases or spinal cord compression, unless treated 4 weeks prior to admission, and stable without steroid treatment for 10 days 22. Uncontrolled hypertension with medical treatment. 23. Previous or current malignancies of other histologies within the previous 5 years. 24. Evidence of severe or poorly controlled systemic disease or any concurrent condition, which in the opinion of the investigator makes the patient´s participation in the study inappropriate or that could risk compliance with the protocol. 25. Enrollment or randomization prior to treatment in the present study. 26. Commitment to conduct the study 27. Participation in a clinical study of any experimental agent within 30 days prior to the start of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of the number of days from randomization to death from any cause. Measure:Time to death (TTD). Timepoints:When the event is presented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Evaluation of the time from the date of randomization to the date of objective progression or death (for any reason in the absence of progression). The progression will be determined according to the Evaluation Criteria of Response in Solid Tumors (RECIST). For them, studies of chest and abdomen images will be used. Criterion 2: ORR is defined as the proportion of subjects with complete and partial response (CR and RP). Where the CR is the disappearance of all lesions white or not white + normalization of the level of the tumor marker. RP refers to at least a 30% decrease in the sum of the DM of the target lesions. Stable disease (SE) is defined as a disease that does not meet response or progression criteria. Disease Control Index (DCR): Proportion of patients with CR, RP or EE ≥ 8 weeks. Measure:1) Free survival of progression (SLP). 2) Objective response index (ORR), disease control and duration of the response. Timepoints:Every 8 weeks from the randomization. ; Outcome name:The levels of plasma proteins VEGF, bFGF and sVEGFR2 in serum samples will be determined. Measure:Pharmacodynamics. Timepoints:At the time of discontinuing the treatment. ; Outcome name:Evaluated using the WHO Functional Status Scale (WHO PS). Measure:Functional status. Timepoints:At the time of discontinuing treatment and during follow-up at 30 days. ; Outcome name:Criterion 1: Evaluation of any adverse event, which is an undesirable clinical condition or the deterioration of a pre-existing clinical condition after or during exposure to a pharmaceutical product, whether or not its causality related to the product is considered. A serious adverse event is one that: 1) Results in death. 2) Attempt immediately against life. 3) Requires hospitalization or prolongation of an existing hospitalization. 4) It results in a persistent or significant disability. 5) Congenital abnormality. Criterion 2: Panels of hemato | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Spain, United Kindgdom
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed