Trial · NCT02365441
A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)
NCT02365441, Phase 2, Unknown, Australasian Gastro-Intestinal Trials Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST). Trials, record NCT02365441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02365441
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)
- NCT number
- NCT02365441
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 78 participants, actual
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Conditions
- Gastrointestinal Stromal Tumour
- Interventions
- Regorafenib, imatinib
- First posted
- 2015-02-19
- Last updated
- 2023-07-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective tumour response (complete or partial response) as determined by RECIST v1.1 | At or before 9 months from the time from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) | The objective tumour response rate (OTRR) will be calculated by summing the number of participants assessed as having a complete or partial response within the first 9 months from the time from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib), and dividing this by the total number of participants evaluable for response. For patients who undergo surgery, the best response is determined in the time period that precedes the date of surgery. The responses are confirmed at the time of the next scheduled imaging, usually done 8 weeks after the first detection of response, provided that imaging of the target lesions is not indicated sooner than this for other reasons. Both the numbers and the proportions of confirmed and unconfirmed responses will be reported. The minimum duration of SD is defined as 8 weeks. |
| Secondary | Progression free survival at 24 months (disease progression or death) | 24 Months | PFS at 24 months as calculated from the time from either (i) randomization if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) to the date of progression as determined by RECIST v1.1 |
| Secondary | Clinical benefit rate at 24 weeks | 24 weeks | Clinical benefit rate (SD + PR + CR) following 2 cycles of treatment |
| Secondary | Time to treatment failure | 5 years | Time to treatment failure is defined as the time from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death. |
| Secondary | Adverse Events | 5 years | Safety/toxicity/tolerability |
| Secondary | Overall survival | 5 years | Overall survival is defined as the interval from either (i) randomization (if patients have not yet commenced treatment) or (ii) commencement of therapy (if patients are randomized during the first cycle of imatinib) to date of death from any cause, or the date of last known follow-up alive. |
| Other | Macroscopically complete removal of all residual disease by surgery | 5 years | This is defined as the rate of patients who proceed to surgery with the aim of resecting all remaining macroscopic disease. |
| Other | Change in PET imaging during washout period of regorafenib and imatinib in those taking part in the PET substudy | 3 years | to explore the relationship between change in PET imaging during washout period of regorafenib and imatinib (in subset of participants at selected centres) |
| Other | Imatinib plasma levels 4 and 12 weeks after commencement of treatment in both arms. Arm B: Imatinib plasma levels at 3 and 11 weeks after commencement of treatment and regorafenib plasma levels 7 and 15 weeks after commencement of treatment. | 3 years | To explore the relationship between study endpoints and Imatinib plasma levels at 4 and 12 weeks after commencement of treatment in both arms. Arm B: Imatinib plasma levels at 3 and 11 weeks after commencement of treatment and regorafenib plasma levels 7 and 15 weeks after commencement of treatment. |
| Other | Change in circulating serum/plasma growth factor and cytokine levels over time(multiplex assay), Frequency of KIT/PDGFRA mutations in circulating blood DNA and DNA load as prognostic and/or predictive markers | 3 years | To explore the relationship between study endpoints and circulating other biomarkers as prognostic and/or predictive markers. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40133509 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02365441
GET https://conductscience.org/api/trials/v1/NCT02365441/registered