Trial Outcomes & Findings for Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT (NCT NCT01151852)

Last Updated: 2020-01-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

81 participants

Primary outcome timeframe

up tp12 weeks

Results posted on

2020-01-14

Participant Flow

Between July 20, 2010, and Jan 17, 81 patients were enrolled in Asan Medical Center, Seoul, Korea.

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).

Participant milestones

Participant milestones
Measure	Imatinib 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.	Placebo 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 Study STARTED	41	40
Overall Study COMPLETED	41	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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 n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	57.9 years STANDARD_DEVIATION 10.4 • n=5 Participants	59.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	58.7 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Korea, Republic of	41 participants n=5 Participants	40 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: up tp12 weeks

Outcome measures

Outcome measures
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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.
Progression-free Survival	1.8 Months Interval 1.7 to 3.6	0.9 Months Interval 0.9 to 1.7

SECONDARY outcome

Timeframe: up to 12 weeks

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.

Outcome measures

Outcome measures
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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.
Disease Control Rate	32 percentage of participants	5 percentage of participants

SECONDARY outcome

Timeframe: up to 12 weeks

To compare PFS assessed by investigators

Outcome measures

Outcome measures
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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.
Progression Free Survival	1.8 Months Interval 1.7 to 2.7	1.7 Months Interval 0.9 to 1.8

SECONDARY outcome

Timeframe: Up to 12weeks

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.

Outcome measures

Outcome measures
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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.
Response Rate	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 3years

To compare the overall survival (OS) and time to progression (TTP) in both arms of the study

Outcome measures

Outcome measures
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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 Survival(OS) and Time to Progression(TTP) Overall survival	8.2 Months Interval 5.5 to 12.8	7.5 Months Interval 4.4 to 12.4
Overall Survival(OS) and Time to Progression(TTP) Time to progression	1.8 Months Interval 1.7 to 3.6	0.9 Months Interval 0.9 to 1.7

SECONDARY outcome

Timeframe: Up to 3years

percentage of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of imatinib re-challenge in this patient population

Outcome measures

Outcome measures
Measure	Imatinib n=41 Participants 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.	Placebo n=40 Participants 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.
Safety and Tolerability of Imatinib	100 percentage of participants	98 percentage of participants

Adverse Events

Imatinib

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Imatinib n=41 participants at risk 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.	Placebo n=40 participants at risk 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.
Musculoskeletal and connective tissue disorders Edema	2.4% 1/41	0.00% 0/40
Gastrointestinal disorders Diarrhea	0.00% 0/41	2.5% 1/40
Gastrointestinal disorders Vomiting	0.00% 0/41	2.5% 1/40

Other adverse events

Other adverse events
Measure	Imatinib n=41 participants at risk 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.	Placebo n=40 participants at risk 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.
Blood and lymphatic system disorders Neutropenia	29.3% 12/41	12.5% 5/40
Blood and lymphatic system disorders Anemia	65.9% 27/41	45.0% 18/40
Blood and lymphatic system disorders Thrombocytopenia	19.5% 8/41	7.5% 3/40
Musculoskeletal and connective tissue disorders Edema	43.9% 18/41	12.5% 5/40
General disorders Fatigue	36.6% 15/41	12.5% 5/40
Gastrointestinal disorders Anorexia	34.1% 14/41	20.0% 8/40
Gastrointestinal disorders Nausea	31.7% 13/41	2.5% 1/40
Gastrointestinal disorders Vomiting	31.7% 13/41	5.0% 2/40
Gastrointestinal disorders Constipation	14.6% 6/41	10.0% 4/40
Gastrointestinal disorders Diarrhea	12.2% 5/41	10.0% 4/40
Hepatobiliary disorders Hyperbilirubinemia	24.4% 10/41	15.0% 6/40
Renal and urinary disorders Azotemia	19.5% 8/41	10.0% 4/40

Additional Information

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place