Trial · NCT00751036

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg

NCT00751036, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2014-03-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg. Trials, record NCT00751036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00751036

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Trial

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

Title: Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg
NCT number: NCT00751036
Status: Terminated
Phases: Phase 3
Enrollment: 94 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Gastrointestinal Stromal Tumors
Interventions: Nilotinib, Imatinib
First posted: 2008-09-11
Last updated: 2014-03-26
Results first posted: 2014-03-26
Limitations and caveats: Patients were limited (planned 300, Actual 94). Early termination of study; not sufficient power to test the original primary hypothesis with respect to PFS. Only descriptive analyses were carried out for this study.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	24 months	Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.
Secondary	Disease Control Rate (DCR)	every 2 months until 24 months (end of study)	The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).
Secondary	Time to Treatment Failure	Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.	TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.
Secondary	Overall Survival (OS)	time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.	. OS is defined as the time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.

Source ClinicalTrials.gov

Outcomes4

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)	24 months	Full Analysis Set (FAS) consisted of all randomized patients. Following the intent to treat principle, patients were analyzed according to the treatment which they were assigned at randomization.	Days	MEDIAN
SECONDARY	Disease Control Rate (DCR)	every 2 months until 24 months (end of study)	Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.	Percentage of Patients	NUMBER
SECONDARY	Time to Treatment Failure	Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.	Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.	Days	MEDIAN
SECONDARY	Overall Survival (OS)	time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.	Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.	Days	MEDIAN

Source ClinicalTrials.gov

Results by group18

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)	Nilotinib		111.00	95% Confidence Interval 83.00 to 190.00	Days
Progression-free Survival (PFS)	Imatinib		120.00	95% Confidence Interval 59.00 to 173.00	Days
Disease Control Rate (DCR)	Nilotinib	Disease Control Rate (CR, PR, or SD)	54.2	95% Confidence Interval 39.2 to 68.6	Percentage of Patients
Disease Control Rate (DCR)	Imatinib	Disease Control Rate (CR, PR, or SD)	47.8	95% Confidence Interval 32.9 to 63.1	Percentage of Patients
Disease Control Rate (DCR)	Nilotinib	Complete Response (CR)	2.1	95% Confidence Interval 0.1 to 11.1	Percentage of Patients
Disease Control Rate (DCR)	Imatinib	Complete Response (CR)	0	95% Confidence Interval 0 to 7.7	Percentage of Patients
Disease Control Rate (DCR)	Nilotinib	Partial Response (PR)	4.2	95% Confidence Interval 0.5 to 14.3	Percentage of Patients
Disease Control Rate (DCR)	Imatinib	Partial Response (PR)	6.5	95% Confidence Interval 1.4 to 17.9	Percentage of Patients
Disease Control Rate (DCR)	Nilotinib	Stable Disease (SD)	47.9	95% Confidence Interval 33.3 to 62.8	Percentage of Patients
Disease Control Rate (DCR)	Imatinib	Stable Disease (SD)	41.3	95% Confidence Interval 27.0 to 56.8	Percentage of Patients

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Nilotinib	48
Overall Study	STARTED	Imatinib	46
Overall Study	COMPLETED	Nilotinib	0
Overall Study	COMPLETED	Imatinib	0
Overall Study	NOT COMPLETED	Nilotinib	48
Overall Study	NOT COMPLETED	Imatinib	46

Source ClinicalTrials.gov

Adverse events164

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 800 mg	14	48
other	Anaemia	Blood and lymphatic system disorders	Imatinib 800 mg	15	46
other	Thrombocytopenia	Blood and lymphatic system disorders	Nilotinib 800 mg	1	48
other	Thrombocytopenia	Blood and lymphatic system disorders	Imatinib 800 mg	3	46
other	Eyelid oedema	Eye disorders	Nilotinib 800 mg	0	48
other	Eyelid oedema	Eye disorders	Imatinib 800 mg	6	46
other	Abdominal distension	Gastrointestinal disorders	Nilotinib 800 mg	4	48
other	Abdominal distension	Gastrointestinal disorders	Imatinib 800 mg	7	46
other	Abdominal pain	Gastrointestinal disorders	Nilotinib 800 mg	8	48
other	Abdominal pain	Gastrointestinal disorders	Imatinib 800 mg	11	46

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nilotinib 800 mg
Total, all-cause mortality	Imatinib 800 mg
Total, other adverse events	Nilotinib 800 mg	39	48
Total, other adverse events	Imatinib 800 mg	41	46
Total, serious adverse events	Nilotinib 800 mg	12	48
Total, serious adverse events	Imatinib 800 mg	10	46

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 comparisons1

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

Comparison
Nilotinib 800 mg vs Imatinib 800 mg: serious adverse events

Source 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/NCT00751036

GET https://conductscience.org/api/trials/v1/NCT00751036/events?page=2

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