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

Phase 2

Completed

Conditions: Stomach Neoplasms

Interventions: Drug: Sunitinib

Registration Number: NCT00226811

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 78

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Sunitinib	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

Primary Outcome Measures

Name	Time	Method
Best Overall Response	From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter	Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Objective Response (Complete Response (CR) or Partial Response (PR))	From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter	Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Secondary Outcome Measures

Name	Time	Method
Time to Tumor Progression (TTP)	From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter	Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.
Progression-Free Survival	From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death	Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.
Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks	From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study	Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.
Duration of Response (CR or PR)	Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer	Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Overall Survival	From start of study treatment until death	Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.