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Trial record 3 of 7 for:    12181401 [PUBMED-IDS]

Rechallenge of Imatinib in GIST Having no Effective Treatment (RIGHT)

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ClinicalTrials.gov Identifier: NCT01151852
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : July 28, 2015
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumors
Interventions Drug: Imatinib
Drug: Placebo
Enrollment 81
Recruitment Details Between July 20, 2010, and Jan 17, 81 patients were enrolled in Asan Medical Center, Seoul, Korea.
Pre-assignment Details Randomization was done in a double-blind manner and stratified by performance status (0-1 vs 2-3) and by the number of previous lines of tyrosine-kinase inhibitor therapy (2 or less vs more than 2).
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent. Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Period Title: Overall Study
Started 41 40
Completed 41 40
Not Completed 0 0
Arm/Group Title Imatinib Placebo Total
Hide Arm/Group Description Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent. Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent. Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
Our analysis was based on intention-to treat population. So, all enrolled patients were analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  70.7%
25
  62.5%
54
  66.7%
>=65 years
12
  29.3%
15
  37.5%
27
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 81 participants
57.9  (10.4) 59.6  (10.6) 58.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
12
  29.3%
14
  35.0%
26
  32.1%
Male
29
  70.7%
26
  65.0%
55
  67.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 41 participants 40 participants 81 participants
41 40 81
1.Primary Outcome
Title Progression-free Survival
Hide Description To compare the progression free survival (PFS) assessed by the blinded independent central review following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with unresectable or metastatic GIST following failure of at least prior imatinib and sunitinib therapies
Time Frame up tp12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Overall Number of Participants Analyzed 41 40
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.7 to 3.6)
0.9
(0.9 to 1.7)
2.Secondary Outcome
Title Disease Control Rate
Hide Description

Inclusion of complete response, partial response or stable disease

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD.

Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: percentage of participants
32 5
3.Secondary Outcome
Title Progression Free Survival
Hide Description To compare PFS assessed by investigators
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Overall Number of Participants Analyzed 41 40
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.7 to 2.7)
1.7
(0.9 to 1.8)
4.Secondary Outcome
Title Response Rate
Hide Description

Tumour responses were initially determined by the local investigators in accordance with RECIST 1.0.Treatment decisions were based on local onsite radiological review. All imaging data were subsequently collected, anonymised, and reviewed centrally in a double-blind manner by two external academic radiology reviewers.

Response assessment was determined in a masked central review by use of RECIST1.1.

Time Frame Up to 12weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: percentage of participants
0 0
5.Secondary Outcome
Title Overall Survival(OS) and Time to Progression(TTP)
Hide Description To compare the overall survival (OS) and time to progression (TTP) in both arms of the study
Time Frame Up to 3years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Overall Number of Participants Analyzed 41 40
Median (95% Confidence Interval)
Unit of Measure: Months
Overall survival
8.2
(5.5 to 12.8)
7.5
(4.4 to 12.4)
Time to progression
1.8
(1.7 to 3.6)
0.9
(0.9 to 1.7)
6.Secondary Outcome
Title Safety and Tolerability of Imatinib
Hide Description percentage of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of imatinib re-challenge in this patient population
Time Frame Up to 3years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description:
Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: percentage of participants
100 98
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imatinib Placebo
Hide Arm/Group Description Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent. Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
All-Cause Mortality
Imatinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Imatinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/41 (2.44%)   2/40 (5.00%) 
Gastrointestinal disorders     
Diarrhea  1 [1]  0/41 (0.00%)  1/40 (2.50%) 
Vomiting  1 [2]  0/41 (0.00%)  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders     
Edema  1 [3]  1/41 (2.44%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI_CTC_version 3.0
[1]
Grade 3 diarrhea
[2]
Grade 3 vomiting
[3]
Grade 3 edema
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imatinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   41/41 (100.00%)   39/40 (97.50%) 
Blood and lymphatic system disorders     
Neutropenia  1  12/41 (29.27%)  5/40 (12.50%) 
Anemia  1  27/41 (65.85%)  18/40 (45.00%) 
Thrombocytopenia  1  8/41 (19.51%)  3/40 (7.50%) 
Gastrointestinal disorders     
Anorexia  1  14/41 (34.15%)  8/40 (20.00%) 
Nausea  1  13/41 (31.71%)  1/40 (2.50%) 
Vomiting  1  13/41 (31.71%)  2/40 (5.00%) 
Constipation  1  6/41 (14.63%)  4/40 (10.00%) 
Diarrhea  1  5/41 (12.20%)  4/40 (10.00%) 
General disorders     
Fatigue  1  15/41 (36.59%)  5/40 (12.50%) 
Hepatobiliary disorders     
Hyperbilirubinemia  1  10/41 (24.39%)  6/40 (15.00%) 
Musculoskeletal and connective tissue disorders     
Edema  1  18/41 (43.90%)  5/40 (12.50%) 
Renal and urinary disorders     
Azotemia  1  8/41 (19.51%)  4/40 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI_CTC_version 3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Yoon-Koo Kang
Organization: Asan Medical Center
Phone: +82-2-3010-3210
Publications:
Responsible Party: Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01151852     History of Changes
Other Study ID Numbers: AMC-ONCGI-1001
First Submitted: June 23, 2010
First Posted: June 29, 2010
Results First Submitted: November 19, 2013
Results First Posted: July 28, 2015
Last Update Posted: July 28, 2015