Trial · NCT00267748
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
NCT00267748, Phase 2, Completed, Pfizer; results first posted 2011-09-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC). Trials, record NCT00267748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00267748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
- NCT number
- NCT00267748
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 317 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Sunitinib Malate Continuous Daily Dosing, Sunitinib Malate Schedule 4/2
- First posted
- 2005-12-21
- Last updated
- 2011-09-05
- Results first posted
- 2011-09-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. |
| Secondary | Percentage of Participants With Objective Response (OR) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 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). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 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 date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
| Secondary | Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=\>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal, Hemoglobin \< lower limit of normal for local lab, Corrected serum calcium \> 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44. |
| Other | Functional Assessment of Cancer Therapy-General (FACT-G) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states. |
| Other | FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | ITT population included all participants who were randomized into the study regardless of whether they received study medication. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | ITT population included all participants who were randomized into the study regardless of whether they received study medication. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Functional Assessment of Cancer Therapy-General (FACT-G) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | ITT population included all participants who were randomized into the study regardless of whether they received study medication. | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS) | From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years | ITT population included all participants who were randomized into the study regardless of whether they received study medication. | Units on scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 50 mg (Schedule 4/2) | Stratified analysis : High Risk (=>3) | 3.1 | 95% Confidence Interval 0.5 to 10.4 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 37.5 mg | Stratified analysis : High Risk (=>3) | 4.4 | 95% Confidence Interval 1.4 to 7.1 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 50 mg (Schedule 4/2) | Stratified analysis : Intermediate Risk (1-2) | 8.0 | 95% Confidence Interval 5.1 to 11.1 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 37.5 mg | Stratified analysis : Intermediate Risk (1-2) | 7.1 | 95% Confidence Interval 5.5 to 10.0 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 50 mg (Schedule 4/2) | Stratified analysis : Low Risk (0) | 20.7 | 95% Confidence Interval 9.9 to 25.2 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 37.5 mg | Stratified analysis : Low Risk (0) | 8.4 | 95% Confidence Interval 7.0 to 21.0 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 50 mg (Schedule 4/2) | Overall unstratified analysis | 9.9 | 95% Confidence Interval 7.0 to 13.4 | Months |
| Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model | Sunitinib 37.5 mg | Overall unstratified analysis | 7.1 | 95% Confidence Interval 6.8 to 9.7 | Months |
| Percentage of Participants With Objective Response (OR) | Sunitinib 50 mg (Schedule 4/2) | 32.2 | 95% Confidence Interval 24.7 to 40.4 | Percentage of participants | |
| Percentage of Participants With Objective Response (OR) | Sunitinib 37.5 mg | 28.1 | 95% Confidence Interval 21.0 to 36.1 | Percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Non-randomized Period | STARTED | Sunitinib 37.5 mg + Interferon Alpha-2b | 25 | |
| Non-randomized Period | STARTED | Sunitinib 50 mg (Schedule 4/2) | 0 | |
| Non-randomized Period | STARTED | Sunitinib 37.5 mg | 0 | |
| Non-randomized Period | COMPLETED | Sunitinib 37.5 mg + Interferon Alpha-2b | 2 | |
| Non-randomized Period | COMPLETED | Sunitinib 50 mg (Schedule 4/2) | 0 | |
| Non-randomized Period | COMPLETED | Sunitinib 37.5 mg | 0 | |
| Non-randomized Period | NOT COMPLETED | Sunitinib 37.5 mg + Interferon Alpha-2b | 23 | |
| Non-randomized Period | NOT COMPLETED | Sunitinib 50 mg (Schedule 4/2) | 0 | |
| Non-randomized Period | NOT COMPLETED | Sunitinib 37.5 mg | 0 | |
| Randomized Period | STARTED | Sunitinib 37.5 mg + Interferon Alpha-2b | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events567
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 | Fatigue | General disorders | Sunitinib 37.5 mg + Interferon Alpha-2b | 25 | 25 | |
| other | Fatigue | General disorders | Sunitinib 50 mg (Schedule 4/2) | 94 | 146 | |
| other | Fatigue | General disorders | Sunitinib 37.5 mg | 100 | 143 | |
| other | Pyrexia | General disorders | Sunitinib 37.5 mg + Interferon Alpha-2b | 8 | 25 | |
| other | Pyrexia | General disorders | Sunitinib 50 mg (Schedule 4/2) | 23 | 146 | |
| other | Pyrexia | General disorders | Sunitinib 37.5 mg | 17 | 143 | |
| other | Chills | General disorders | Sunitinib 37.5 mg + Interferon Alpha-2b | 7 | 25 | |
| other | Chills | General disorders | Sunitinib 50 mg (Schedule 4/2) | 14 | 146 | |
| other | Chills | General disorders | Sunitinib 37.5 mg | 18 | 143 | |
| other | Influenza like illness | General disorders | Sunitinib 37.5 mg + Interferon Alpha-2b | 6 | 25 |
1 to 10 of 567Source ClinicalTrials.gov
See all 567 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib 37.5 mg + Interferon Alpha-2b | ||
| Total, all-cause mortality | Sunitinib 50 mg (Schedule 4/2) | ||
| Total, all-cause mortality | Sunitinib 37.5 mg | ||
| Total, other adverse events | Sunitinib 37.5 mg + Interferon Alpha-2b | 25 | 25 |
| Total, other adverse events | Sunitinib 50 mg (Schedule 4/2) | 144 | 146 |
| Total, other adverse events | Sunitinib 37.5 mg | 142 | 143 |
| Total, serious adverse events | Sunitinib 37.5 mg + Interferon Alpha-2b | 7 | 25 |
| Total, serious adverse events | Sunitinib 50 mg (Schedule 4/2) | 50 | 146 |
| Total, serious adverse events | Sunitinib 37.5 mg | 54 | 143 |
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/NCT00267748
GET https://conductscience.org/api/trials/v1/NCT00267748/results?page=2