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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00226811
First received: September 23, 2005
Last updated: March 10, 2015
Last verified: March 2015

September 23, 2005
March 10, 2015
January 2006
May 2008   (final data collection date for primary outcome measure)
  • Best Overall Response [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
    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)) [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
    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.
Overall confirmed objective response rate
Complete list of historical versions of study NCT00226811 on ClinicalTrials.gov Archive Site
  • Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer ] [ Designated as safety issue: No ]
    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.
  • Progression-Free Survival [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ] [ Designated as safety issue: No ]
    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.
  • Time to Tumor Progression (TTP) [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
    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.
  • Overall Survival [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
    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.
Clinical Benefit Rate, Progression-free survival; Time to progression; Duration of Response, Overall survival; Probability of survival at 1 year, Quality of Life, safety, pk, biomarkers
Not Provided
Not Provided
 
An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
Drug: 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
Experimental: A
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
Intervention: Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Portugal,   Taiwan
 
NCT00226811
A6181054
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP