Trial · NCT00428597
A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
NCT00428597, Phase 3, Terminated, Pfizer; results first posted 2010-10-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors. Trials, record NCT00428597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00428597
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
- NCT number
- NCT00428597
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 171 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Islet Cell, Carcinoma, Pancreas
- Interventions
- sunitinib malate, Placebo
- First posted
- 2007-01-30
- Last updated
- 2010-10-11
- Results first posted
- 2010-10-11
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death | Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4. |
| Secondary | Number of Subjects With Objective Response | From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter | Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Duration of Response (DR) | From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause | Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. |
| Secondary | Time-to-Tumor Response (TTR) | From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter | Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. |
| Secondary | Overall Survival (OS) | From start of study treatment up to 22 months | Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm. |
| Secondary | European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
| Secondary | EORTC QLQ-C30 - Cognitive Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
| Secondary | EORTC QLQ-C30 - Emotional Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
| Secondary | EORTC QLQ-C30 - Physical Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
| Secondary | EORTC QLQ-C30 - Role Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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) | From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death | Intent-to-treat (ITT) population = all subjects who were randomized. | Months | MEDIAN |
| SECONDARY | Number of Subjects With Objective Response | From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter | ITT. No placebo subjects had objective response. | participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause | ITT. DR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for DR; no placebo subjects reported CR or PR. | Months | MEDIAN |
| SECONDARY | Time-to-Tumor Response (TTR) | From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter | ITT. TTR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for TTR; no placebo subjects reported CR or PR. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From start of study treatment up to 22 months | ITT. The median OS in months could not be calculated for placebo. | months | MEDIAN |
| SECONDARY | European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | Patient Reported Outcome (PRO) population=subjects from the ITT population who had completed at least 1 EORTC QLQ-C30 assessment while on treatment. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability. | scores on a scale | MEAN |
| SECONDARY | EORTC QLQ-C30 - Cognitive Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles with less than 10 subjects are not reported due to lack of statistical reliability. | scores on a scale | MEAN |
| SECONDARY | EORTC QLQ-C30 - Emotional Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability. | scores on a scale | MEAN |
| SECONDARY | EORTC QLQ-C30 - Physical Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability. | scores on a scale | MEAN |
| SECONDARY | EORTC QLQ-C30 - Role Functioning Subscale | Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal | PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability. | scores on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group306
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) | Sunitinib | 11.4 | 95% Confidence Interval 7.4 to 19.8 | Months | |
| Progression Free Survival (PFS) | Placebo | 5.5 | 95% Confidence Interval 3.6 to 7.4 | Months | |
| Number of Subjects With Objective Response | Sunitinib | 8 | participants | ||
| Duration of Response (DR) | Sunitinib | 8.1 | Full Range 1.0 to 15.0 | Months | |
| Time-to-Tumor Response (TTR) | Sunitinib | 3.1 | Full Range 0.8 to 11.1 | Months | |
| Overall Survival (OS) | Sunitinib | 20.6 | 95% Confidence Interval 20.6 to NA | months | |
| European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Sunitinib | Cycle 1 (n=66, 66) | 67.0 | Standard Deviation 20.3 | scores on a scale |
| European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Placebo | Cycle 1 (n=66, 66) | 64.0 | Standard Deviation 22.7 | scores on a scale |
| European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Sunitinib | Cycle 2 (n=68, 66) | 62.1 | Standard Deviation 19.9 | scores on a scale |
| European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale | Placebo | Cycle 2 (n=68, 66) | 62.6 | Standard Deviation 23.6 | scores on a scale |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib | 86 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | Received Treatment | Sunitinib | 83 | |
| Overall Study | Received Treatment | Placebo | 82 | |
| Overall Study | COMPLETED | Sunitinib | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib | 86 | |
| Overall Study | NOT COMPLETED | Placebo | 85 |
Source ClinicalTrials.gov
Adverse events286
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 | Anaemia | Blood and lymphatic system disorders | Sunitinib | 4 | 83 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 8 | 82 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib | 8 | 83 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 1 | 82 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 23 | 83 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 3 | 82 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 13 | 83 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 4 | 82 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib | 6 | 83 | |
| other | Hypothyroidism | Endocrine disorders | Placebo | 1 | 82 |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sunitinib | 80 | 83 |
| Total, other adverse events | Placebo | 70 | 82 |
| Total, serious adverse events | Sunitinib | 22 | 83 |
| Total, serious adverse events | Placebo | 34 | 82 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Sunitinib vs Placebo: 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.
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/NCT00428597
GET https://conductscience.org/api/trials/v1/NCT00428597/results?page=2