Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)
|ClinicalTrials.gov Identifier: NCT00793871|
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : May 1, 2015
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors||Drug: Sunitinib Malate (SU011248)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate|
|Study Start Date :||November 2008|
|Primary Completion Date :||April 2014|
|Study Completion Date :||October 2014|
U.S. FDA Resources
single agent sunitinib, single arm
Drug: Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
- Progression-free Survival (PFS) [ Time Frame: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks) ]PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.
- Overall Survival (OS) [ Time Frame: Baseline (Day 1) to death (up to 282 weeks) ]
OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.
In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
- Objective Response Rate (ORR) [ Time Frame: Baseline (Day 1) up to end of study treatment (up to 276 weeks) ]ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Time to Tumor Progression (TTP) [ Time Frame: Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks) ]TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.
- Number of Participants With Abnormal Clinical Laboratory Measurements [ Time Frame: Baseline up to 28 days post last administration of study drug ]The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.
- Number of Participants With Significant Changes From Baseline in Physical Examination. [ Time Frame: Baseline up to 28 days post last administration of study drug ]Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.
- Number of Participants With Significant Vital Signs Changes From Baseline [ Time Frame: Baseline (Day 1) up to 28 days post last administration of study drug ]Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline.
- Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug) ]ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).
- Time to Tumor Response (TTR) [ Time Frame: Baseline (Day 1) to tumor response (up to 82 weeks) ]TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793871
|Nanjing Bayi Hospital|
|Nanjing, Jiangsu, China, 210002|
|Beijing Cancer Hospital|
|Beijing, China, 100035|
|307 Hospital of PLA|
|Beijing, China, 100071|
|Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC|
|Bejing, China, 100021|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|