Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00793871
First received: November 17, 2008
Last updated: May 4, 2015
Last verified: May 2015
  Purpose

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.


Condition Intervention Phase
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Drug: Sunitinib Malate (SU011248)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Day 1) to death (up to 282 weeks) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • Time to Tumor Response (TTR) [ Time Frame: Baseline (Day 1) to tumor response (up to 82 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: November 2008
Study Completion Date: October 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793871

Locations
China, Jiangsu
Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
China
307 Hospital of PLA
Beijing, China, 100071
Beijing Cancer Hospital
Beijing, China, 100035
Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC
Bejing, China, 100021
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00793871     History of Changes
Other Study ID Numbers: A6181177
Study First Received: November 17, 2008
Results First Received: April 14, 2015
Last Updated: May 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
sunitinib
Phase IV
gastrointestinal stomal tumor
imatinib resistant or intolerant
Chinese

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Imatinib
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015