Skip to main content
OpenTrials
Completed

NCT Number: NCT00226811

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Nanjing, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

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 outcomes

  1. Best Overall Response

    Time frame: 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.

  2. 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

    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 outcomes

  1. 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

    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.

  2. Duration of Response (CR or PR)

    Time frame: 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.

  3. Progression-Free Survival

    Time frame: 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.

  4. Time to Tumor Progression (TTP)

    Time frame: 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.

  5. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 27, 2005
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.