Trial · NCT03353753

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies

NCT03353753, Phase 3, Completed, Deciphera Pharmaceuticals, LLC; results first posted 2021-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies. Trials, record NCT03353753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03353753

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
NCT number: NCT03353753
Status: Completed
Phases: Phase 3
Enrollment: 129 participants, actual
Lead sponsor: Deciphera Pharmaceuticals, LLC
Conditions: Gastrointestinal Stromal Tumors
Interventions: DCC-2618, Placebo Oral Tablet
First posted: 2017-11-27
Last updated: 2022-11-21
Results first posted: 2021-04-23

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS)	From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].	PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
Secondary	Objective Response Rate (ORR)	From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].	The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: \>=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.
Secondary	Time to Tumor Progression (TTP) Based on Independent Radiologic Review	From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].	TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.
Secondary	Overall Survival (OS)	From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].	Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.
Secondary	Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning	From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)	Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
Secondary	Quality of Life & Disease-Related Symptoms - Physical Functioning	From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)	Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
Secondary	Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale	From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)	Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.

Source ClinicalTrials.gov

Outcomes7

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)	From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].	ITT Population	Weeks	MEDIAN
SECONDARY	Objective Response Rate (ORR)	From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].	ITT Population	Percentage of Participants	NUMBER
SECONDARY	Time to Tumor Progression (TTP) Based on Independent Radiologic Review	From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].	ITT Population	Weeks	MEDIAN
SECONDARY	Overall Survival (OS)	From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].	ITT Population	weeks	MEDIAN
SECONDARY	Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning	From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)	ITT Population	units on a scale	MEAN
SECONDARY	Quality of Life & Disease-Related Symptoms - Physical Functioning	From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)	ITT Population	units on a scale	MEAN
SECONDARY	Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale	From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)	ITT Population	Units on a Scale	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-Free Survival (PFS)	Ripretinib	27.6	95% Confidence Interval 20.0 to 29.9	Weeks
Progression-Free Survival (PFS)	Placebo	4.1	95% Confidence Interval 4.0 to 7.3	Weeks
Objective Response Rate (ORR)	Ripretinib	9.4	95% Confidence Interval 4.2 to 17.7	Percentage of Participants
Objective Response Rate (ORR)	Placebo	0	95% Confidence Interval 0.0 to 8.0	Percentage of Participants
Time to Tumor Progression (TTP) Based on Independent Radiologic Review	Ripretinib	28	95% Confidence Interval 20.0 to 36.4	Weeks
Time to Tumor Progression (TTP) Based on Independent Radiologic Review	Placebo	4.1	95% Confidence Interval 4.0 to 7.6	Weeks
Overall Survival (OS)	Ripretinib	65.6	95% Confidence Interval 53.6 to 65.6	weeks
Overall Survival (OS)	Placebo	28.6	95% Confidence Interval 17.9 to 50.4	weeks
Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning	Ripretinib	3.5	Standard Deviation 27.31	units on a scale
Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning	Placebo	-17.1	Standard Deviation 30.28	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ripretinib	85
Overall Study	STARTED	Placebo	44
Overall Study	COMPLETED	Ripretinib	46
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Ripretinib	39
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events176

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
other	Anemia	Blood and lymphatic system disorders	Ripretinib	12	85
other	Anemia	Blood and lymphatic system disorders	Placebo	8	43
other	Nausea	Gastrointestinal disorders	Ripretinib	33	85
other	Nausea	Gastrointestinal disorders	Placebo	5	43
other	Abdominal Pain	Gastrointestinal disorders	Ripretinib	31	85
other	Abdominal Pain	Gastrointestinal disorders	Placebo	13	43
other	Constipation	Gastrointestinal disorders	Ripretinib	29	85
other	Constipation	Gastrointestinal disorders	Placebo	8	43
other	Diarrhea	Gastrointestinal disorders	Ripretinib	24	85
other	Diarrhea	Gastrointestinal disorders	Placebo	6	43

1 to 10 of 176Source ClinicalTrials.gov

See all 176 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ripretinib	26	85
Total, all-cause mortality	Placebo	26	43
Total, other adverse events	Ripretinib	84	85
Total, other adverse events	Placebo	42	43
Total, serious adverse events	Ripretinib	26	85
Total, serious adverse events	Placebo	19	43

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32511981	DERIVED	PubMed
34661454	DERIVED	PubMed
36514034	DERIVED	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ripretinib vs Placebo: deaths from any cause	Trial comparisons
Ripretinib vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03353753

GET https://conductscience.org/api/trials/v1/NCT03353753/events?page=2

API reference For AI assistants