Clinical trial NCT00226811: An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Best Overall Response
timeFrame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
measure: Objective Response (Complete Response (CR) or Partial Response (PR))
timeFrame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
Secondary outcomes:
measure: Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks
timeFrame: 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
measure: Duration of Response (CR or PR)
timeFrame: Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer
measure: Progression-Free Survival
timeFrame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death
measure: Time to Tumor Progression (TTP)
timeFrame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter
measure: Overall Survival
timeFrame: From start of study treatment until death
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Ancona
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Kashiwa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Suntougun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Kwei-Shan
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: