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

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

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

1.  Primary:

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

2.  Primary:

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

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. ]

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. ]

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. ]

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 ]

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. ]

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. ]

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. ]

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. ]

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. ]

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. ]

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.