AN OPEN LABEL INTERNATIONAL MULTI-CENTER PHASE 2 ACTIVITY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH ADVANCED / METASTATIC GASTRIC CANCER PROGRESSING OR RECURRING AFTER ONE PRIOR CHEMOTHERAPY

Phase 1

Conditions: 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: 7.1Level: LLYClassification code 10017758

Registration Number: EUCTR2005-000524-16-PT

Lead Sponsor: aboratorios Pfizer, Lda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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

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 <4 weeks of starting the study treatment.
Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is
at least one measurable lesion that has not been irradiated.
3. Prior radiation therapy to >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 <4 weeks of starting study treatment.
6. Inability to swallow oral medications, or presence of active inflammatory bowel
disease, partial or complete bowel obstruction or chronic diarrhea.
7. Known brain metastases, or spinal cord compression, or carcinomatous meningitis
(baseline CT or magnetic resonance imaging [MRI] scan of the brain required only
in case of clinical suspicion of central nervous system metastases).
8. Diagnosis of any second malignancy within the last 3 years, except for adequately
treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix
uteri.
9. Any of the following within the 12 months prior to study drug administration:
severe/unstable angina, myocardial infarction, coronary artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident, including
transient ischemic attack, or pulmonary embolism.
10. Ongoing cardiac dysrhythmias of NCI CTCAE grade major than /equal to 2, atrial
fibrillation of any grade, or prolongation of the QTc interval to >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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>• To evaluate the safety and tolerability of SU011248<br>• To explore the effects of SU011248 on patient reported outcomes of health related <br> quality of life (HRQOL) and gastric cancer specific symptoms.<br>• To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to <br> correlate these plasma concentrations with activity and safety parameters<br>• 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

Secondary Outcome Measures

Name	Time	Method

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