Trial · NCT00338884
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
NCT00338884, Phase 2, Completed, Pfizer; results first posted 2011-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer. Trials, record NCT00338884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00338884
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
- NCT number
- NCT00338884
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Sunitinib malate
- First posted
- 2006-06-20
- Last updated
- 2012-08-31
- Results first posted
- 2011-06-14
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Overall Confirmed Objective Response (OR) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter | OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting \> = 4 weeks after initial documentation of response. 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 Weeks 5, 9, and every 8 weeks thereafter or death due to any cause | Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as \[the end date for DR minus first CR or PR that was subsequently confirmed +1\]/7. |
| Secondary | Time to Tumor Progression (TTP) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter | Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST. |
| Secondary | Progression-Free Survival (PFS) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death | Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7. |
| Secondary | 1-Year Survival | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year | One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment. |
| Secondary | Trough Plasma Concentrations (Ctrough) of Sunitinib | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | Ctrough = the concentration prior to study drug administration. |
| Secondary | Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. |
| Secondary | Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented. |
| Secondary | Ctrough of SU-012662 (Sunitinib's Metabolite) | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | Ctrough = the concentration prior to study drug administration. |
| Secondary | Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Overall Confirmed Objective Response (OR) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter | Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis. | participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause | Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response. | months | MEAN |
| SECONDARY | Time to Tumor Progression (TTP) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter | Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death | Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis. | months | MEDIAN |
| SECONDARY | 1-Year Survival | From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year | Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis. | percent chance of survival | MEDIAN |
| SECONDARY | Trough Plasma Concentrations (Ctrough) of Sunitinib | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point. | nanograms (ng)/milliliter (mL) | MEAN |
| SECONDARY | Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | ng/mL | MEDIAN |
| SECONDARY | Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | ng/mL | MEDIAN |
| SECONDARY | Ctrough of SU-012662 (Sunitinib's Metabolite) | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point. | ng/mL | MEAN |
| SECONDARY | Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite) | Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53 | PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33. | ng/mL | MEDIAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group389
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Overall Confirmed Objective Response (OR) | Sunitinib | 41 | participants | ||
| Duration of Response (DR) | Sunitinib | 7.14 | 95% Confidence Interval 6.28 to 8.00 | months | |
| Time to Tumor Progression (TTP) | Sunitinib | 10.0 | 95% Confidence Interval 7.2 to NA | months | |
| Progression-Free Survival (PFS) | Sunitinib | 9.0 | 95% Confidence Interval 5.6 to 11.1 | months | |
| 1-Year Survival | Sunitinib | 67.8 | 95% Confidence Interval 59.2 to 76.3 | percent chance of survival | |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | Sunitinib | Day 1, Week 1 (n=111) | 7.15 | Standard Deviation 18.80 | nanograms (ng)/milliliter (mL) |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | Sunitinib | Day 1, Week 3 (n=108) | 54.78 | Standard Deviation 23.67 | nanograms (ng)/milliliter (mL) |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | Sunitinib | Day 1, Week 5 (n=106) | 45.64 | Standard Deviation 22.83 | nanograms (ng)/milliliter (mL) |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | Sunitinib | Day 1, Week 7 (n=104) | 46.35 | Standard Deviation 21.98 | nanograms (ng)/milliliter (mL) |
| Trough Plasma Concentrations (Ctrough) of Sunitinib | Sunitinib | Day 1, Week 9 (n=97) | 47.54 | Standard Deviation 24.96 | nanograms (ng)/milliliter (mL) |
1 to 10 of 389Source ClinicalTrials.gov
See all 389 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib | 120 | |
| Overall Study | Received Treatment | Sunitinib | 119 | |
| Overall Study | COMPLETED | Sunitinib | 42 | |
| Overall Study | NOT COMPLETED | Sunitinib | 78 |
Source ClinicalTrials.gov
Adverse events120
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 | 26 | 119 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 22 | 119 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 17 | 119 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib | 7 | 119 | |
| other | Abdominal distension | Gastrointestinal disorders | Sunitinib | 7 | 119 | |
| other | Abdominal pain | Gastrointestinal disorders | Sunitinib | 18 | 119 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sunitinib | 16 | 119 | |
| other | Constipation | Gastrointestinal disorders | Sunitinib | 22 | 119 | |
| other | Diarrhoea | Gastrointestinal disorders | Sunitinib | 62 | 119 | |
| other | Dry mouth | Gastrointestinal disorders | Sunitinib | 7 | 119 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib | ||
| Total, other adverse events | Sunitinib | 117 | 119 |
| Total, serious adverse events | Sunitinib | 45 | 119 |
Source ClinicalTrials.gov
Papers4
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 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/NCT00338884
GET https://conductscience.org/api/trials/v1/NCT00338884/registered?page=2