Trial · NCT04633122
A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib
NCT04633122, Phase 2, Completed, Zai Lab (Shanghai) Co., Ltd.; results first posted 2025-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib. Trials, record NCT04633122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04633122
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib
- NCT number
- NCT04633122
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Conditions
- Gastrointestinal Stromal Tumor(GIST)
- Interventions
- Ripretinib, Sunitinib
- First posted
- 2020-11-18
- Last updated
- 2026-04-03
- Results first posted
- 2025-01-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Approximately 12 months. | PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes. |
| Secondary | Objective Response Rate (ORR) | Approximately 12 months. | The percentage of participants whose efficacy is confirmed as complete response (CR) or partial responses (PR) based on independent radiology review. |
| Secondary | Disease Control Rate (DCR) | Approximately 12 months. | The percentage of participants whose efficacy is confirmed as complete response (CR) or partial responses (PR) or duration of SD ≥ 12 months based on independent radiology review. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Approximately 12 months. | months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | Approximately 12 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control Rate (DCR) | Approximately 12 months. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Ripretinib | 10.3 | 95% Confidence Interval 5.5 to NA | months | |
| Progression-free Survival (PFS) | Sunitinib | 8.3 | 95% Confidence Interval 4.9 to NA | months | |
| Objective Response Rate (ORR) | Ripretinib | 16 | Participants | ||
| Objective Response Rate (ORR) | Sunitinib | 11 | Participants | ||
| Disease Control Rate (DCR) | Ripretinib | 24 | Participants | ||
| Disease Control Rate (DCR) | Sunitinib | 20 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ripretinib | 54 | |
| Overall Study | STARTED | Sunitinib | 54 | |
| Overall Study | COMPLETED | Ripretinib | 13 | |
| Overall Study | COMPLETED | Sunitinib | 15 | |
| Overall Study | NOT COMPLETED | Ripretinib | 41 | |
| Overall Study | NOT COMPLETED | Sunitinib | 39 |
Source ClinicalTrials.gov
Adverse events184
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 | Alopecias | Skin and subcutaneous tissue disorders | Ripretinib | 27 | 54 | |
| other | Alopecias | Skin and subcutaneous tissue disorders | Sunitinib | 3 | 54 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Ripretinib | 23 | 54 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Sunitinib | 4 | 54 | |
| other | Anaemia | Blood and lymphatic system disorders | Ripretinib | 17 | 54 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 40 | 54 | |
| other | Hypothyroidism | Endocrine disorders | Ripretinib | 10 | 54 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib | 17 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | Ripretinib | 16 | 54 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib | 10 | 54 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ripretinib | 13 | 54 |
| Total, all-cause mortality | Sunitinib | 15 | 54 |
| Total, other adverse events | Ripretinib | 54 | 54 |
| Total, other adverse events | Sunitinib | 54 | 54 |
| Total, serious adverse events | Ripretinib | 9 | 54 |
| Total, serious adverse events | Sunitinib | 12 | 54 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ripretinib vs Sunitinib: Objective Response Rate (ORR) | Trial comparisons |
| Ripretinib vs Sunitinib: deaths from any cause | Trial comparisons |
| Ripretinib vs Sunitinib: Disease Control Rate (DCR) | Trial comparisons |
| Ripretinib vs Sunitinib: serious adverse events | 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/NCT04633122
GET https://conductscience.org/api/trials/v1/NCT04633122/events?page=2