Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

NCT01694277

Gastrointestinal Stromal Tumors

COMPLETED PHASE3

Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

NCT00573404

Gastrointestinal Stromal Tumor

TERMINATED PHASE1

To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

NCT03424876

GIST

UNKNOWN

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg

NCT00751036

Gastrointestinal Stromal Tumors

TERMINATED PHASE3

A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

NCT00940563

Advanced Gastrointestinal Stromal Tumors

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Stromal Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

sunitinib malate

Intervention Type DRUG

37.5 mg daily

B

Group Type ACTIVE_COMPARATOR

imatinib mesylate

Intervention Type DRUG

800mg daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sunitinib malate

37.5 mg daily

Intervention Type DRUG

imatinib mesylate

800mg daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sutent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion Criteria

* Current treatment with any chemotherapy other than imatinib.
* Current treatment with any dose of imatinib other than 400 mg

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer Inc

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Review additional registry numbers or institutional identifiers associated with this trial.

A6181112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene

NCT00237185 COMPLETED PHASE2

Imatinib Mesylate in Treating Patients With Primary Gastrointestinal Stromal Tumor That Has Been Completely Removed By Surgery

NCT00041197 COMPLETED PHASE3

Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT

NCT01151852 COMPLETED PHASE3

Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib

NCT00688766 TERMINATED PHASE3

A Retrospective Pharmacokinetics and Pharmacogenomics Research of Imatinib in Gastrointestinal Stromal Tumor Treatment

NCT03092128 UNKNOWN

Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor

NCT00685828 UNKNOWN PHASE3

Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor

NCT00103168 COMPLETED PHASE3

Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)

NCT05009927 RECRUITING PHASE2

A Study to Investigate the Safety and Efficacy of AT13387, Alone or in Combination With Imatinib, in Patients With GIST

NCT01294202 COMPLETED PHASE2

Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

NCT00009906 TERMINATED PHASE3

Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

NCT00324987 TERMINATED PHASE3

Long-term Surival of GIST Patients ≥ 10 Years on Imatinib

NCT04097093 WITHDRAWN

Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

NCT00764595 COMPLETED PHASE2

Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib

NCT02607332 COMPLETED PHASE2

Safety and Efficacy Evaluation of Two Year Imatinib Treatment in Adjuvant Gastrointestinal Stromal Tumor (GIST)

NCT01172548 COMPLETED PHASE2

Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery

NCT00025246 COMPLETED PHASE2

Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

NCT00171977 COMPLETED PHASE4

Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST)

NCT00867113 COMPLETED PHASE2

Correlation Between Imatinib Trough Concentration and Efficacy in Advanced GIST Patients with Different Genotypes

NCT06628739 COMPLETED

A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

NCT00075218 COMPLETED PHASE3

Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)

NCT01483014 COMPLETED PHASE2

Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index

NCT02576080 UNKNOWN PHASE3

Entacapone Combination With Imatinib for Treatment of GIST

NCT04006769 COMPLETED EARLY_PHASE1

Sarcopenia in Patients With Gastrointestinal Stromal Tumours

NCT02877368 COMPLETED

A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments

NCT05152472 RECRUITING PHASE2

Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg

A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

Detailed Description

Conditions

Study Design

Study Groups

A

sunitinib malate

B

imatinib mesylate

Interventions

sunitinib malate

imatinib mesylate

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Pfizer Investigational Site

Countries

Related Links

Other Identifiers

A6181112

More Related Trials