ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures

Not Applicable

• Conditions: -C349 Bronchus or lung, unspecified; Bronchus or lung, unspecified; C349

• Registration Number: PER-108-06
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified