Trial · NCT00785785

A Study of Nilotinib Versus Imatinib in GIST Patients

NCT00785785, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-04-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Nilotinib Versus Imatinib in GIST Patients. Trials, record NCT00785785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00785785

On this page

Trial

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

Title: A Study of Nilotinib Versus Imatinib in GIST Patients
NCT number: NCT00785785
Status: Completed
Phases: Phase 3
Enrollment: 644 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Gastrointestinal Stromal Tumor (GIST)
Interventions: Nilotinib (AMN107), imatinib (STI571)
First posted: 2008-11-05
Last updated: 2016-06-16
Other registries' IDs: eudract:2008-004758-34
Results first posted: 2016-04-07

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Time to Progression Free Survival (PFS)	up to month 37	PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Progression Free Survival (PFS)	up to month 37	Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.	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
Time to Progression Free Survival (PFS)	Nilotinib		25.9	Full Range 0 to 32.8	months
Time to Progression Free Survival (PFS)	Imatinib		29.7	Full Range 0 to 36.1	months

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Core Phase up to 36 Months	STARTED	Imatinib First, Then Nilotinib	324
Core Phase up to 36 Months	STARTED	Nilotinib First, Then Imatinib	320
Core Phase up to 36 Months	COMPLETED	Imatinib First, Then Nilotinib	0
Core Phase up to 36 Months	COMPLETED	Nilotinib First, Then Imatinib	0
Core Phase up to 36 Months	NOT COMPLETED	Imatinib First, Then Nilotinib	324
Core Phase up to 36 Months	NOT COMPLETED	Nilotinib First, Then Imatinib	320
Optional Extension Phase	STARTED	Imatinib First, Then Nilotinib	39
Optional Extension Phase	STARTED	Nilotinib First, Then Imatinib	125
Optional Extension Phase	COMPLETED	Imatinib First, Then Nilotinib	0
Optional Extension Phase	COMPLETED	Nilotinib First, Then Imatinib	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,112

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	Anaemia	Blood and lymphatic system disorders	Nilotinib	38	321
other	Anaemia	Blood and lymphatic system disorders	Imatinib	61	316
other	Anaemia	Blood and lymphatic system disorders	Crossover Nilotinib	7	39
other	Anaemia	Blood and lymphatic system disorders	Crossover Imatinib	20	125
other	Leukopenia	Blood and lymphatic system disorders	Nilotinib	4	321
other	Leukopenia	Blood and lymphatic system disorders	Imatinib	35	316
other	Leukopenia	Blood and lymphatic system disorders	Crossover Nilotinib	1	39
other	Leukopenia	Blood and lymphatic system disorders	Crossover Imatinib	10	125
other	Neutropenia	Blood and lymphatic system disorders	Nilotinib	4	321
other	Neutropenia	Blood and lymphatic system disorders	Imatinib	42	316

1 to 10 of 1,112Source ClinicalTrials.gov

See all 1,112 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nilotinib
Total, all-cause mortality	Imatinib
Total, all-cause mortality	Crossover Nilotinib
Total, all-cause mortality	Crossover Imatinib
Total, other adverse events	Nilotinib	291	321
Total, other adverse events	Imatinib	289	316
Total, other adverse events	Crossover Nilotinib	28	39
Total, other adverse events	Crossover Imatinib	89	125
Total, serious adverse events	Nilotinib	80	321
Total, serious adverse events	Imatinib	85	316

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25882987	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/NCT00785785

GET https://conductscience.org/api/trials/v1/NCT00785785/events?page=2

API reference For AI assistants