An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

Pfizer

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00226811

A6181054

Details and patient eligibility

About

The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented
• Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion
• Evidence of measurable disease by radiographic technique
• Adequate organ function.

Exclusion criteria

• Clinically relevant ascites (i.e. requiring paracentesis)
• Severe weight loss
• NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment
• Diagnosis of second malignancy within last 3 years
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
• Known HIV
• Serious acute or chronic illness
• Current treatment on another clinical trial
• Pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

A

Experimental group

Description:

50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed

Treatment:

Drug: Sunitinib