Histologically proven NSCLC (Stage IV or recurrent disease or locally advanced [Stage IIIB]) that is not amenable to surgery, radiation, or combined modality therapy with curative intent
Conditions
Interventions
Product Name: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sal L-malato de SU011248
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Pfizer S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven NSCLC (Stage IV or recurrent disease or locally advanced [Stage IIIB]) that is not amenable to surgery, radiation, or combined modality therapy with curative intent. 2. Must have received no more than 2 prior systemic chemotherapy regimens including treatment with platinum and docetaxel (Taxotere)-containing regimens. 3. Must have evidence of progression of disease within 6 months of most recent prior systemic anticancer therapy. 4. Completion of all prior chemotherapy, immunotherapy, and radiotherapy > /equal to 4 weeks prior to study entry, and resolution of all acute toxic effects of any prior systemic anticancer therapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade minor/equal to 1. 5. Evidence of unidimensionally measurable disease (i.e., > /equal 1 malignant tumor mass that may be accurately measured in at least 1 dimension > /equal to 20 mm with conventional radiographic techniques or magnetic resonance imaging [MRI], or if spiral computerized tomography [CT] scan, twice the reconstruction interval used [lesion size > /equal to 10-16 mm depending on interval]). Tumor evaluation by positron emission tomography (PET) scan or by ultrasound may not substitute for CT or MRI scans. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions, and disease documented by indirect evidence only (e.g., by laboratory tests such as alkaline phosphatase) are not considered measurable. 6. Male or female, 18 years of age or older. 7. ECOG performance status 0 or 1. 8. Adequate organ function as defined by the following criteria: · Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase) [SGPT] minor/equal to 2.5 x upper limit of normal (ULN) · Total serum bilirubin minor/equal to1.5 mg/dL · Prothrombin time (PT) minor/equal to1.5 x ULN · Absolute neutrophil count (ANC) major/equal to 1500/mL · Platelets major/equal to 100,000/mL · Hemoglobin major/equal to 9.0 g/dL · Serum creatinine minor/equal to 1.5 x ULN · Left ventricular ejection fraction (LVEF) major/equal to 50% as assessed by multigated acquisition (MUGA) scan 9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Major surgery or radiation therapy 450 msec for males or >470 msec for females. 10. Known human immunodeficiency virus (HIV) infection. 11. Current treatment on another clinical trial. 12. Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 21 days prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. 13. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. 14. Receipt of any investigational agent within 4 weeks prior to study entry. Previous treatment with SU011248
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the antitumor efficacy of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks repeated every 6 weeks in patients having metastatic NSCLC who have previously failed a platinum-containing regimen and docetaxel (Taxotere);Secondary Objective: To assess duration of response· To assess time to progression· To assess survival· To evaluate the safety and tolerability of SU011248 · To evaluate SU011248 and SU012662 trough concentrations (Cmin) and to correlate these plasma concentrations with efficacy and safety parameters· To explore the relationship of cancer biomarkers with cancer and treatment-related outcomes;Primary end point(s): Overall confirmed objective response rate (ORR). | — |
Countries
Italy, Spain
Outcome results
None listed