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Sunitinib

Imatinib Mesylate

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Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

Sunitinib Malate (SU011248)

Pfizer CT.gov Call Center

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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).

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.

Sutent (Sunitinib Malate)

Age, Continuous

Sex: Female, Male

Safety analysis set included all participants who started study treatment.

Pfizer ClinicalTrials.gov Call Center

Safety analysis included all participants who started study treatment.

Progression-free Survival (PFS)

Overall Survival (OS)

The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.

Objective Response Rate (ORR)

Time to Tumor Progression (TTP)

All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.

Time to Tumor Response (TTR)

Number of Participants With Abnormal Clinical Laboratory Measurements

Number of Participants With Significant Changes From Baseline in Physical Examination.

SBP >150 mm Hg or DBP >100 mm Hg

SBP >200 mm Hg or DBP >110 mm Hg

heart rate: <50 bpm

heart rate: >120 bpm

heart rate: >=30 bpm increase from baseline

heart rate: >=30 bpm decrease from baseline

temperature: >38.3°C

temperature: >=1.1°C increase (baseline >=36.8°C)

respiration rate: <8/minute

respiration rate: >40/minute

weight: >=5% increase from baseline

weight: >=5% decrease from baseline

Number of Participants With Significant Vital Signs Changes From Baseline

Baseline, ECOG = 0

Baseline, ECOG = 1

Baseline, ECOG = 2

Baseline, ECOG = 3

Baseline, ECOG = 4

Baseline, ECOG = 5

Last on treatment, ECOG = 0

Last on treatment, ECOG = 1

Last on treatment, ECOG = 2

Last on treatment, ECOG = 3

Last on treatment, ECOG = 4

Last on treatment, ECOG = 5

Eastern Cooperative Oncology Group (ECOG) Performance Status

The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.

Spots Global Cancer Trial Database for gastrointestinal neoplasms, gastrointestinal stromal tumors