Trial · NCT02164240

Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST

NCT02164240, Phase 1, Completed, Dana-Farber Cancer Institute; results first posted 2019-09-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST. Trials, record NCT02164240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02164240

On this page

Trial

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

Title: Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST
NCT number: NCT02164240
Status: Completed
Phases: Phase 1
Enrollment: 14 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Gastrointestinal Stromal Tumor
Interventions: Sunitinib, Regorafenib
First posted: 2014-06-16
Last updated: 2021-06-14
Results first posted: 2019-09-12

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Serious and Non-Serious Adverse Events	Up to Day 28	Dose-escalation cohort is to determine the frequency and characteristics of DLTs of alternation of sunitinib and regorafenib at each dose level during the first cycle of therapy. Toxicity will be graded accordingly with NCI CTCAE version 4.0
Secondary	Percentage of Participants With Clinical Benefit	16 weeks	Percentage of participants who experienced complete response, partial response or stable disease per RECIST 1.1 at 16 weeks
Secondary	Median Progression Free Survival (mPFS)	From date of registration until date of protocol-defined progression while on this protocol, assessed up to 6 months	Non-parametric Kaplan-Meier analysis to assess median progression free survival (mPFS)

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	Number of Participants With Serious and Non-Serious Adverse Events	Up to Day 28		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Clinical Benefit	16 weeks	clinical benefit was analyzed across the entire population based on the pre-planned study design	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Progression Free Survival (mPFS)	From date of registration until date of protocol-defined progression while on this protocol, assessed up to 6 months	all patients enrolled were analyzed as a single cohort for this endpoint based on pre-planned study design	months	MEDIAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Number of Participants With Serious and Non-Serious Adverse Events	Sunitinib 37.5 and Regorafenib 120	4		Participants
Number of Participants With Serious and Non-Serious Adverse Events	Sunitinib 37.5 and Regorafenib 160	5		Participants
Number of Participants With Serious and Non-Serious Adverse Events	Expansion Sunitinib 37.5 Regorafenib 120	4		Participants
Percentage of Participants With Clinical Benefit	Sunitinib and Regorafenib	0		Participants
Median Progression Free Survival (mPFS)	Sunitinib and Regorafenib	1.9	95% Confidence Interval 1.4 to 3.6	months

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sunitinib 37.5 and Regorafenib 120	4
Overall Study	STARTED	Sunitinib 37.5 and Regorafenib 160	5
Overall Study	STARTED	Expansion Sunitinib 37.5 Regorafenib 120	4
Overall Study	COMPLETED	Sunitinib 37.5 and Regorafenib 120	4
Overall Study	COMPLETED	Sunitinib 37.5 and Regorafenib 160	5
Overall Study	COMPLETED	Expansion Sunitinib 37.5 Regorafenib 120	4
Overall Study	NOT COMPLETED	Sunitinib 37.5 and Regorafenib 120	0
Overall Study	NOT COMPLETED	Sunitinib 37.5 and Regorafenib 160	0
Overall Study	NOT COMPLETED	Expansion Sunitinib 37.5 Regorafenib 120	0

Source ClinicalTrials.gov

Adverse events108

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	Abdominal pain	Gastrointestinal disorders	Cohort 1: SuRe120	2	4
other	Abdominal pain	Gastrointestinal disorders	Cohort 2: SuRe160	0	5
other	Abdominal pain	Gastrointestinal disorders	Cohort 3: ExpSuRe120	0	4
other	Bloating	Gastrointestinal disorders	Cohort 1: SuRe120	1	4
other	Bloating	Gastrointestinal disorders	Cohort 2: SuRe160	0	5
other	Bloating	Gastrointestinal disorders	Cohort 3: ExpSuRe120	0	4
other	Constipation	Gastrointestinal disorders	Cohort 1: SuRe120	1	4
other	Constipation	Gastrointestinal disorders	Cohort 2: SuRe160	1	5
other	Constipation	Gastrointestinal disorders	Cohort 3: ExpSuRe120	0	4
other	Diarrhea	Gastrointestinal disorders	Cohort 1: SuRe120	4	4

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1: SuRe120	0	4
Total, all-cause mortality	Cohort 2: SuRe160	0	5
Total, all-cause mortality	Cohort 3: ExpSuRe120	0	4
Total, other adverse events	Cohort 1: SuRe120	4	4
Total, other adverse events	Cohort 2: SuRe160	5	5
Total, other adverse events	Cohort 3: ExpSuRe120	4	4
Total, serious adverse events	Cohort 1: SuRe120	2	4
Total, serious adverse events	Cohort 2: SuRe160	3	5
Total, serious adverse events	Cohort 3: ExpSuRe120	2	4

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31471313	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.

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/NCT02164240

GET https://conductscience.org/api/trials/v1/NCT02164240/events?page=2

API reference For AI assistants