Trial · NCT00716820
Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
NCT00716820, Completed, Pfizer; results first posted 2016-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan). Trials, record NCT00716820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00716820
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
- NCT number
- NCT00716820
- Status
- Completed
- Enrollment
- 472 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- SUNITINIB MALATE
- First posted
- 2008-07-16
- Last updated
- 2023-04-06
- Results first posted
- 2016-10-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). |
| Primary | Objective Response Rate | MAX 2 Years | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI). |
| Secondary | Objective Response Rates by KIT Expression Status | MAX 2 Years | Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs. |
| Secondary | Objective Response Rates by c-Kit Mutation Status | MAX 2 Years | Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs. |
| Secondary | Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | MAX 2 Years | Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs. |
| Secondary | Number of Participants With Treatment-Related Adverse Events in Elderly Population | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment | MAX 2 Years | A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Treatment-Related Adverse Events | MAX 2 Years | Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once. | Participants | NUMBER |
| PRIMARY | Objective Response Rate | MAX 2 Years | Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rates by KIT Expression Status | MAX 2 Years | Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rates by c-Kit Mutation Status | MAX 2 Years | Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | MAX 2 Years | Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events in Elderly Population | MAX 2 Years | Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment | MAX 2 Years | Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment | MAX 2 Years | Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors | MAX 2 Years | Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment | MAX 2 Years | Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | Sunitinib Malate | 450 | Participants | ||
| Objective Response Rate | Sunitinib Malate | 20.1 | 95% Confidence Interval 16.2 to 24.4 | Percentage of participants | |
| Objective Response Rates by KIT Expression Status | KIT Positive | 21.2 | 95% Confidence Interval 17.0 to 26.0 | Percentage of participants | |
| Objective Response Rates by KIT Expression Status | KIT Negative | 12.5 | 95% Confidence Interval 0.3 to 52.7 | Percentage of participants | |
| Objective Response Rates by KIT Expression Status | Unknown | 11.9 | 95% Confidence Interval 4.0 to 25.6 | Percentage of participants | |
| Objective Response Rates by c-Kit Mutation Status | c-Kit With Mutation | 22.1 | 95% Confidence Interval 13.4 to 33.0 | Percentage of participants | |
| Objective Response Rates by c-Kit Mutation Status | c-Kit Without Mutation | 20.0 | 95% Confidence Interval 4.3 to 48.1 | Percentage of participants | |
| Objective Response Rates by c-Kit Mutation Status | Unknown | 19.5 | 95% Confidence Interval 15.2 to 24.5 | Percentage of participants | |
| Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | PDGFRα With Mutation | 20.0 | 95% Confidence Interval 0.5 to 71.6 | Percentage of participants | |
| Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status | PDGFRα Without Mutation | 27.8 | 95% Confidence Interval 14.2 to 45.2 | Percentage of participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib Malate | 472 | |
| Overall Study | COMPLETED | Sunitinib Malate | 472 | |
| Overall Study | NOT COMPLETED | Sunitinib Malate | 0 |
Source ClinicalTrials.gov
Adverse events265
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 | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib Malate | 18 | 472 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib Malate | 10 | 472 | |
| other | Bone marrow failure | Blood and lymphatic system disorders | Sunitinib Malate | 7 | 472 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib Malate | 10 | 472 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib Malate | 61 | 472 | |
| other | Left ventricular dysfunction | Cardiac disorders | Sunitinib Malate | 6 | 472 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib Malate | 113 | 472 | |
| other | Hyperthyroidism | Endocrine disorders | Sunitinib Malate | 17 | 472 | |
| other | Eyelid oedema | Eye disorders | Sunitinib Malate | 5 | 472 | |
| other | Nausea | Gastrointestinal disorders | Sunitinib Malate | 68 | 472 |
1 to 10 of 265Source ClinicalTrials.gov
See all 265 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib Malate | ||
| Total, other adverse events | Sunitinib Malate | 429 | 472 |
| Total, serious adverse events | Sunitinib Malate | 259 | 472 |
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 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.
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/NCT00716820
GET https://conductscience.org/api/trials/v1/NCT00716820/results?page=2