Trial · NCT01151852
Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT
NCT01151852, Phase 3, Completed, Asan Medical Center; results first posted 2015-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT. Trials, record NCT01151852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01151852
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT
- NCT number
- NCT01151852
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- Asan Medical Center
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Imatinib, Placebo
- First posted
- 2010-06-29
- Last updated
- 2020-01-14
- Results first posted
- 2015-07-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | up tp12 weeks | 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 |
| Secondary | Disease Control Rate | 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. |
| Secondary | Progression Free Survival | up to 12 weeks | To compare PFS assessed by investigators |
| Secondary | Response Rate | 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. |
| Secondary | Overall Survival(OS) and Time to Progression(TTP) | Up to 3years | To compare the overall survival (OS) and time to progression (TTP) in both arms of the study |
| Secondary | Safety and Tolerability of Imatinib | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | up tp12 weeks | Months | MEDIAN | |
| SECONDARY | Disease Control Rate | up to 12 weeks | percentage of participants | NUMBER | |
| SECONDARY | Progression Free Survival | up to 12 weeks | Months | MEDIAN | |
| SECONDARY | Response Rate | Up to 12weeks | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival(OS) and Time to Progression(TTP) | Up to 3years | Months | MEDIAN | |
| SECONDARY | Safety and Tolerability of Imatinib | Up to 3years | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Imatinib | 1.8 | 95% Confidence Interval 1.7 to 3.6 | Months | |
| Progression-free Survival | Placebo | 0.9 | 95% Confidence Interval 0.9 to 1.7 | Months | |
| Disease Control Rate | Imatinib | 32 | percentage of participants | ||
| Disease Control Rate | Placebo | 5 | percentage of participants | ||
| Progression Free Survival | Imatinib | 1.8 | 95% Confidence Interval 1.7 to 2.7 | Months | |
| Progression Free Survival | Placebo | 1.7 | 95% Confidence Interval 0.9 to 1.8 | Months | |
| Response Rate | Imatinib | 0 | percentage of participants | ||
| Response Rate | Placebo | 0 | percentage of participants | ||
| Overall Survival(OS) and Time to Progression(TTP) | Imatinib | Overall survival | 8.2 | 95% Confidence Interval 5.5 to 12.8 | Months |
| Overall Survival(OS) and Time to Progression(TTP) | Placebo | Overall survival | 7.5 | 95% Confidence Interval 4.4 to 12.4 | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib | 41 | |
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | COMPLETED | Imatinib | 41 | |
| Overall Study | COMPLETED | Placebo | 40 | |
| Overall Study | NOT COMPLETED | Imatinib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib | 12 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 5 | 40 | |
| other | Anemia | Blood and lymphatic system disorders | Imatinib | 27 | 41 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 18 | 40 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib | 8 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 3 | 40 | |
| other | Edema | Musculoskeletal and connective tissue disorders | Imatinib | 18 | 41 | |
| other | Edema | Musculoskeletal and connective tissue disorders | Placebo | 5 | 40 | |
| other | Fatigue | General disorders | Imatinib | 15 | 41 | |
| other | Fatigue | General disorders | Placebo | 5 | 40 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Imatinib | 41 | 41 |
| Total, other adverse events | Placebo | 39 | 40 |
| Total, serious adverse events | Imatinib | 1 | 41 |
| Total, serious adverse events | Placebo | 2 | 40 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Imatinib vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01151852
GET https://conductscience.org/api/trials/v1/NCT01151852/events?page=2