Back to resultsSafety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)
Primary Purpose
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sunitinib Malate (SU011248)
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors focused on measuring sunitinib, Phase IV, gastrointestinal stomal tumor, imatinib resistant or intolerant, Chinese
Eligibility Criteria
Inclusion Criteria:
- Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
- Evidence of unidimensionally measurable disease
- Failure of prior treatment with imatinib or intolerant to imatinib
- Male or female, 18 years of age or older.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
- Resolution of all acute toxic effects
- Adequate organ function.
Exclusion Criteria:
- Anticancer treatment after last dose of imatinib
- Major surgery within 4 weeks or radiation therapy within 2 weeks.
- Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
- Diagnosis of second malignancy within the last 5 years.
- History of brain disease.
- Cardiac disease within 12 months.
- Thyroid function abnormality.
- Ongoing cardiac dysrhythmias.
- Uncontrolled hypertension.
- Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
- HIV or AIDS related illness.
- Pregnancy or breastfeeding.
Sites / Locations
- Nanjing Bayi Hospital
- Beijing Cancer Hospital
- 307 Hospital of PLA
- Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sunitinib
Arm Description
single agent sunitinib, single arm
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
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.
Secondary Outcome Measures
Overall Survival (OS)
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)
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)
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
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.
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00793871
Brief Title
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Acronym
GIST
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Keywords
sunitinib, Phase IV, gastrointestinal stomal tumor, imatinib resistant or intolerant, Chinese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sunitinib
Arm Type
Experimental
Arm Description
single agent sunitinib, single arm
Intervention Type
Drug
Intervention Name(s)
Sunitinib Malate (SU011248)
Intervention Description
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Baseline (Day 1) to death (up to 282 weeks)
Title
Objective Response Rate (ORR)
Description
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 Frame
Baseline (Day 1) up to end of study treatment (up to 276 weeks)
Title
Time to Tumor Progression (TTP)
Description
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.
Time Frame
Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)
Title
Number of Participants With Abnormal Clinical Laboratory Measurements
Description
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.
Time Frame
Baseline up to 28 days post last administration of study drug
Title
Number of Participants With Significant Changes From Baseline in Physical Examination.
Description
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.
Time Frame
Baseline up to 28 days post last administration of study drug
Title
Number of Participants With Significant Vital Signs Changes From Baseline
Description
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.
Time Frame
Baseline (Day 1) up to 28 days post last administration of study drug
Title
Eastern Cooperative Oncology Group (ECOG) Performance Status
Description
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 Frame
Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)
Other Pre-specified Outcome Measures:
Title
Time to Tumor Response (TTR)
Description
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.
Time Frame
Baseline (Day 1) to tumor response (up to 82 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
Evidence of unidimensionally measurable disease
Failure of prior treatment with imatinib or intolerant to imatinib
Male or female, 18 years of age or older.
ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Resolution of all acute toxic effects
Adequate organ function.
Exclusion Criteria:
Anticancer treatment after last dose of imatinib
Major surgery within 4 weeks or radiation therapy within 2 weeks.
Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
Diagnosis of second malignancy within the last 5 years.
History of brain disease.
Cardiac disease within 12 months.
Thyroid function abnormality.
Ongoing cardiac dysrhythmias.
Uncontrolled hypertension.
Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
HIV or AIDS related illness.
Pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Bayi Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
307 Hospital of PLA
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC
City
Bejing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181177
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
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