Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (i.e. an adenocarcinoma with >50% extension in the stomach). Patients must present with stage IV disease not amenable to surgery, radiation, or combined modality therapy with curative intent. MedDRA version: 7.1 Level: LLY Classification code 10017758
Conditions
Interventions
Product Code: SU011248 L-Malate Salt
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Laboratorios Pfizer, Lda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (i.e. an adenocarcinoma with >50% extension in the stomach). 2. Patients must present with stage IV disease not amenable to surgery, radiation, or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred. 3. Patients must present with disease progression or recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose >/= 4 weeks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion. 4. Resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, or prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ?1. 5. Measurable disease according to RECIST. 6. Male or female, 18 years of age or older. 7. ECOG performance status minor than /equal to 1. 8. Adequate organ function as defined by the following criteria: • Absolute neutrophil count (ANC) major than/equal to 1,500/microL • Platelets major than/equal 100,000/microL • Hemoglobin major than/equal 9.0 g/dL • Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase) [SGPT] less than/equal to 2.5 x upper limit of normal (ULN), less than/equal to 5 x ULN if there is liver involvement secondary to tumor. • Total serum bilirubin less than/equal to 1.5 mg/dL (less than/equal to 2.2 mg/dL in presence of Gilbert’s disease) regardless of liver involvement secondary to tumor. • Prothrombin time (PT) less than/equal to 1.5 x ULN • Serum creatinine less than/equal to 1.5 x ULN. 9. Life-expectancy of more than/equal to 3 months. 10. 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. 11. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. More than one prior chemotherapy regimen for advanced / metastatic disease. 2. Major surgery or radiation therapy 25% of the bone marrow. 4. Presence of clinically relevant ascites (i.e. requiring paracentesis) and/or major than/equal to NCI CTCAE Grade 2 weight loss. 5. NCI CTCAE Grade 3 hemorrhage 450 msec for males or >470 msec for females. 11. Hypertension that cannot be controlled by medications (blood pressure >150/90 mmHg despite optimal medical therapy). 12. Treatment with anticonvulsant agents and treatment with therapeutic doses of Coumadin currently or within 2 weeks prior to first day of SU011248 administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day). Low molecular weight heparin is allowed. 13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 14. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 21 days prior to enrollment. 15. 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. 16. Prior treatment on a SU011248 trial. 17. Receipt of any investigational agent within 4 weeks prior to study entry. 18. Current treatment on another therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the antitumor activity of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks repeated every 6 weeks in patients with advanced / metastatic gastric cancer, after failure of one prior chemotherapy regimen for advanced / metastatic disease.;Secondary Objective: • To assess measures of clinical benefit and duration of tumor control • To evaluate the safety and tolerability of SU011248 • To explore the effects of SU011248 on patient reported outcomes of health related quality of life (HRQOL) and gastric cancer specific symptoms. • To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to correlate these plasma concentrations with activity and safety parameters • To explore the correlations of cancer biomarkers with cancer- and treatment-related outcomes.;Primary end point(s): Objective response rate (ORR) as determined according to RECIST | — |
Countries
Italy, Portugal
Outcome results
None listed