Trial · NCT01068769

Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

NCT01068769, Phase 2, Completed, Suzanne George, MD; results first posted 2014-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor. Trials, record NCT01068769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01068769

On this page

Trial

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

Title: Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
NCT number: NCT01068769
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Suzanne George, MD
Conditions: Gastrointestinal Stromal Tumor
Interventions: regorafenib
First posted: 2010-02-15
Last updated: 2020-08-24
Results first posted: 2014-02-24

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control	2 years	The composite of complete response, partial response, and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control. This is for target lesions. Complete response is disappearance of all target lesions and partial response is \>+30% decrease in the sum of the longest diameter of target lesions. Stable disease is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions. Progressive disease is considered an increase of the sum of the longest diameter of target lesions by greater than or equal to 20%.
Secondary	Progression-free Survival (PFS)	From date of enrollment until date of first documented progression or date of death from any cause, whichever came first	Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control	2 years		percentage of participants	NUMBER
SECONDARY	Progression-free Survival (PFS)	From date of enrollment until date of first documented progression or date of death from any cause, whichever came first		months	MEDIAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control	Regorafenib		75	95% Confidence Interval 61 to 91	percentage of participants
Progression-free Survival (PFS)	Regorafenib		10.0	95% Confidence Interval 8.3 to 14.9	months

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Regorafenib	34
Overall Study	COMPLETED	Regorafenib	33
Overall Study	NOT COMPLETED	Regorafenib	1

Source ClinicalTrials.gov

Adverse events104

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	Leukocytosis	Blood and lymphatic system disorders	Regorafenib	3	33
other	Anemia	Blood and lymphatic system disorders	Regorafenib	9	33
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	Regorafenib	3	33
other	Hyperthyroidism	Endocrine disorders	Regorafenib	3	33
other	Hypothyroidism	Endocrine disorders	Regorafenib	5	33
other	Eye disorders - Other, specify	Eye disorders	Regorafenib	3	33
other	Bloating	Gastrointestinal disorders	Regorafenib	2	33
other	Oral dysesthesia	Gastrointestinal disorders	Regorafenib	6	33
other	Abdominal distension	Gastrointestinal disorders	Regorafenib	4	33
other	Abdominal pain	Gastrointestinal disorders	Regorafenib	8	33

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regorafenib
Total, other adverse events	Regorafenib	33	33
Total, serious adverse events	Regorafenib	31	33

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27371698	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/NCT01068769

GET https://conductscience.org/api/trials/v1/NCT01068769/events?page=2

API reference For AI assistants