Gastrointestinal Stromal TumorsPhase 1/2NCT00457743

A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)

A Phase 1/2 study testing Sunitinib malate (SU011248) in people with Gastrointestinal Stromal Tumors, run by Pfizer at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Gastrointestinal Stromal Tumors
What is being tested?: Sunitinib malate (SU011248)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 4 sitesJapan
Study dates: Jan 2005to Aug 2008
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
Patients previously treated with imatinib mesylate.

Who cannot join

Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

Pfizer Investigational Site
Chuo-ku, Tokyo
Pfizer Investigational Site
Kashiwa, Chiba
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Suita, Osaka

Other trials in Japan

About this study

Official title: A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Conditions: Gastrointestinal Stromal Tumors
Being tested: Sunitinib malate (SU011248)
Keywords: Evaluate of RTD for Japanese GIST patients
Medical subject headings: Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sunitinib malate (SU011248)Drug
SU011248

Study groups in NCT00457743
Study group	Role	What they receive
SU011248	Experimental	25 , 50 or 75 mg/day of SU011248 Receives: Drug: Sunitinib malate (SU011248)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Dose Limiting Toxicities (DLT)
Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.
Measured: Cycle 1 (Baseline to Week 6)
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1
Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Measured: Day 1 of Cycle 1
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28
Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Measured: Day 28 of Cycle 1
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1
Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Measured: Day 1 of Cycle 1
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28
Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Measured: Day 28 of Cycle 1
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1
Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662).
Measured: Day 1 of Cycle 1
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28
Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.
The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662).
Measured: Day 28 of Cycle 1
SU-011248 Clearance on Cycle 1 Day 28
SU-011248 Clearance in the subjects enrolled in Phase 1.
Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL).
Measured: Day 28 of Cycle 1
Accumulation Ratio (Rac) on Cycle 1 Day 28
Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1.
Rac was the ratio of Day 28 to Day 1.
Measured: Day 28 of Cycle 1
Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group
Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Day 28 of Cycles 1-4

Secondary outcomes (14)

Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)
Measured: Day 1, 14, 28 of Cycles 1-4
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Measured: Day 1, 14, 28 of Cycles 1-4
Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)
Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)
Measured: Day 1, 14, 28 of Cycles 1-4
Trough Plasma Concentration (Ctrough) of SU-011248
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Measured: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-012262
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Measured: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Measured: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires
Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A).
The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated.
Change from Baseline: Score at each observation minus score at baseline
Measured: Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires
The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health.
Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline
Measured: Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4
Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group
Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Day 28 of Cycles 1-4
Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group
Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Day 28 of Cycles 1-4
Time To Tumor Progression (TTP)
Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).
Measured: From the first dose to Progressive Disease
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.
Measured: From the first dose to Progressive Disease or Death
Time To Failure (TTF)
Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.
Measured: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
Overall Survival Time
Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive.
Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once.
Measured: From the first dose to death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Aug 2008

First posted6 Apr 2007 (estimated)
Study startJan 2005
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00457743
Sponsor's protocol ID: A6181045
Other IDs: JapicCTI-070386
Status last verified: Oct 2009
First submitted: 4 Apr 2007
Last updated: 13 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Patient-Derived 3D Bioprinted Colorectal Cancer-Stroma-Immune Triad Model Uncovers Microenvironmental Mechanisms of Chemoresistance and Immune Evasion
Colorectal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer

All Gastrointestinal Stromal Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
ClinicalTrials.gov ID: NCT00457743
Acronym / sponsor ID: A6181045
Conditions: Gastrointestinal Stromal Tumors
Keywords: Evaluate of RTD for Japanese GIST patients
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 6 Apr 2007 (estimated)
Results: Posted 13 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SU011248	Experimental	Drug: Sunitinib malate (SU011248)25 , 50 or 75 mg/day of SU011248

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
Patients previously treated with imatinib mesylate.

Key exclusion criteria (2 listed)

Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sunitinib malate (SU011248)SU011248	Drug	SU011248

Primary outcome

Number of Subjects With Dose Limiting Toxicities (DLT)
Time frame: Cycle 1 (Baseline to Week 6)
Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1
Time frame: Day 1 of Cycle 1
Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28
Time frame: Day 28 of Cycle 1
Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1
Time frame: Day 1 of Cycle 1
Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28
Time frame: Day 28 of Cycle 1
Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1
Time frame: Day 1 of Cycle 1
Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662).
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28
Time frame: Day 28 of Cycle 1
Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662).
SU-011248 Clearance on Cycle 1 Day 28
Time frame: Day 28 of Cycle 1
SU-011248 Clearance in the subjects enrolled in Phase 1. Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL).
Accumulation Ratio (Rac) on Cycle 1 Day 28
Time frame: Day 28 of Cycle 1
Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1. Rac was the ratio of Day 28 to Day 1.
Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group
Time frame: Day 28 of Cycles 1-4
Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).

14 secondary outcomes

Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Time frame: Day 1, 14, 28 of Cycles 1-4
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Time frame: Day 1, 14, 28 of Cycles 1-4
Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)
Time frame: Day 1, 14, 28 of Cycles 1-4
Trough Plasma Concentration (Ctrough) of SU-011248
Time frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-012262
Time frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662
Time frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires
Time frame: Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires
Time frame: Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4
Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group
Time frame: Day 28 of Cycles 1-4
Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group
Time frame: Day 28 of Cycles 1-4
Time To Tumor Progression (TTP)
Time frame: From the first dose to Progressive Disease
Progression-Free Survival (PFS)
Time frame: From the first dose to Progressive Disease or Death
Time To Failure (TTF)
Time frame: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
Overall Survival Time
Time frame: From the first dose to death

Results and safety

Results posted to the registry on 13 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SU-011248 25-mg	3	0
SU-011248 50-mg	30	3
SU-011248 75-mg	3	0

Primary outcome: Number of Subjects With Dose Limiting Toxicities (DLT)

Time frame: Cycle 1 (Baseline to Week 6). Number. Unit: participants

Measure	SU-011248 25-mg n = 3	SU-011248 50-mg n = 6	SU-011248 75-mg n = 2
Value	0	0	2

Population analysed: DLT analysis population consists of subjects who developed DLT or received 85% of the planned dose. One subject in 75-mg dose group was excluded from DLT analysis population because the subject received less than 85% of the planned dose.

Primary outcome: Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1

Time frame: Day 1 of Cycle 1. Mean (Standard Deviation). Unit: ng/mL

Measure	SU-011248 25-mg n = 3	SU-011248 50-mg n = 6	SU-011248 75-mg n = 3
SU-011248	12.1 (4.9)	22.8 (6.4)	32.3 (20.8)
SU-012662	1.96 (1.27)	4.13 (0.93)	4.81 (2.54)
SU-011248+SU-012662	14.1 (6.1)	26.7 (7.4)	37.0 (22.1)

Population analysed: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.

Primary outcome: Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28

Time frame: Day 28 of Cycle 1. Mean (Standard Deviation). Unit: ng/mL

Measure	SU-011248 25-mg n = 3	SU-011248 50-mg n = 6
SU-011248	39.5 (25.0)	69.3 (18.9)
SU-012662	15.2 (10.2)	38.8 (16.0)
SU-011248+SU-012662	54.0 (32.2)	105 (35)

Population analysed: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis. 3 subjects in 75mg dose group discontinued before Cycle 1 Day 28, therefore no data presented.

Primary outcome: Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1

Time frame: Day 1 of Cycle 1. Mean (Standard Deviation). Unit: ng•h/mL

Measure	SU-011248 25-mg n = 3	SU-011248 50-mg n = 6	SU-011248 75-mg n = 3
SU-011248	199 (89)	374 (69)	508 (259)
SU-012662	30.9 (20.6)	70.0 (14.4)	91.1 (45.3)
SU-011248+SU-012662	230 (108)	444 (82)	599 (287)

Population analysed: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SU-011248 25-mg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
SU-011248 50-mg	12 of 30 (40%)	30 of 30 (100%)	Not reported
SU-011248 75-mg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Gastrointestinal Stromal Tumors

RecruitingObservational study
A Patient-Derived 3D Bioprinted Colorectal Cancer-Stroma-Immune Triad Model Uncovers Microenvironmental Mechanisms of Chemoresistance and Immune Evasion
Colorectal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sunitinib malate (SU011248) in people with Gastrointestinal Stromal Tumors, run by Pfizer at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Dose Limiting Toxicities (DLT) (time frame: Cycle 1 (Baseline to Week 6)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00457743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.