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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
Intervention:	Drug: Imatinib mesylate

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Imatinib Mesylate 400 mg	imatinib mesylate 400 mg once daily
Imatinib Mesylate 600 mg	imatinib mesylate 600 mg once daily

Participant Flow for 2 periods

Period 1:   Core

	Imatinib Mesylate 400 mg	Imatinib Mesylate 600 mg
STARTED	74	74
Treated Participants	73	74
COMPLETED	30	37
NOT COMPLETED	44	37
Adverse Event	3	4
Abnormal laboratory value	0	4
Abnormal test procedure results	1	0
Lack of Efficacy	30	23
Protocol Violation	1	1
Withdrawal by Subject	4	4
Administrative problems	0	1
Death	4	0
Determined ineligible post randomization	1	0

Period 2:   Extension

	Imatinib Mesylate 400 mg	Imatinib Mesylate 600 mg
STARTED	24 [1]	32 [1]
COMPLETED	8	13
NOT COMPLETED	16	19
Adverse Event	1	0
Abnormal laboratory value	0	1
Lack of Efficacy	9	14
Condition no longer required study drug	0	1
Withdrawal by Subject	3	2
Lost to Follow-up	1	0
Administrative problems	1	0
Death	1	1

[1]	A portion of the participants, who completed the core, entered the extension.

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Imatinib Mesylate 400 mg	400 mg Imatinib mesylate
Imatinib Mesylate 600 mg	600 mg Imatinib mesylate
Total	Total of all reporting groups

Baseline Measures

	Imatinib Mesylate 400 mg	Imatinib Mesylate 600 mg	Total
Overall Participants Analyzed; [Units: Participants]	73	74	147
Age; [Units: Years]; Mean (Standard Deviation)	56.6 (12.9)	52.2 (11.12)	54.4 (12.2)
Gender; [Units: Participants]
Female	29	35	64
Male	44	39	83

  Outcome Measures

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1. Primary:

Best Tumor Response (Core) [ Time Frame: Month 36 ]

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2. Primary:

Best Tumor Response (Core + Extension) [ Time Frame: Month 156 ]

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3. Secondary:

Overall Survival (Core) [ Time Frame: Date of first imatinib dose to the date of death during the core period, up to 36 months. ]

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4. Secondary:

Overall Survival (Core + Extension) [ Time Frame: Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months. ]

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5. Secondary:

Duration of Response (Core) [ Time Frame: Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months. ]

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6. Secondary:

Duration of Response (Core + Extension) [ Time Frame: Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months ]

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7. Secondary:

Progression Free Survival (PFS) (Core + Extension) [ Time Frame: Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months. ]

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8. Secondary:

Time to Treatment Failure (Core) [ Time Frame: Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months. ]

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9. Secondary:

Time to Treatment Failure (Core + Extension) [ Time Frame: Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month. ]

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10. Secondary:

Time to Onset of Response (Core) [ Time Frame: Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months. ]

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11. Secondary:

Time to Onset of Response (Core + Extension) [ Time Frame: Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months. ]

  Show Outcome Measure 11

12. Secondary:

Time to Progression (Core + Extension) [ Time Frame: Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months. ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No safety data was collected in the extension.

  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact:  

Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00237185 History of Changes
Other Study ID Numbers:	CSTI571B2222; CSTI571B2222/E1
First Submitted:	October 9, 2005
First Posted:	October 12, 2005
Results First Submitted:	June 13, 2014
Results First Posted:	July 15, 2014
Last Update Posted:	August 19, 2014