Trial · NCT00700258
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
NCT00700258, Completed, Pfizer; results first posted 2024-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]. Trials, record NCT00700258. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00700258
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
- NCT number
- NCT00700258
- Status
- Completed
- Enrollment
- 1,520 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors
- Interventions
- Temsirolimus, Temsirolimus, Sunitinib, Sunitinib, Axitinib
- First posted
- 2008-06-18
- Last updated
- 2024-09-23
- Results first posted
- 2024-09-23
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method. |
| Primary | Progression Free Survival (PFS) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented "non-progression" was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to "1 day". Kaplan-Meier method was used for analysis. |
| Primary | Number of Participants With Best Overall Response (BOR) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (\<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported. |
| Primary | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion. |
| Primary | Karnofsky Performance Status (KPS) Scale | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. |
| Primary | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2) and missing was evaluated for MCL as planned. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events. |
| Primary | Number of Participants Who Discontinued Treatment Due to Adverse Events | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported. |
| Primary | Number of Participants Categorized According to Physician's Global Tolerability Assessment | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion. |
| Primary | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Week 46 up to Week 55 post study inclusion |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | Effectiveness analysis set (EAS): all participants included in study with at least 1 information on: date of death, progression, assessment of response to therapy by physician or assessment to either effectiveness or tolerability of therapy by physician. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. | Months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. | Months | MEDIAN |
| PRIMARY | Number of Participants With Best Overall Response (BOR) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, 'Number Analyzed' signifies those participants who were evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Categorized According to Physician's Global Assessment of Effectiveness | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Karnofsky Performance Status (KPS) Scale | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed for MCL. | Units on a scale | MEAN |
| PRIMARY | Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | Safety analysis set (SAS) comprised of all prospectively documented participants with histologically proven diagnosis of either mRCC, MCL or GIST and at least 1 documented administration of temsirolimus, sunitinib or axitinib or any non-Pfizer treatment. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Treatment Due to Adverse Events | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Categorized According to Physician's Global Tolerability Assessment | From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months | SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit | Week 46 up to Week 55 post study inclusion | SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows. | Percentage of blood cells in blood | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | mRCC - Temsirolimus | 11.04 | 95% Confidence Interval 9.56 to 13.04 | Months | |
| Overall Survival (OS) | mRCC - Sunitinib | 25.36 | 95% Confidence Interval 22.18 to 28.22 | Months | |
| Overall Survival (OS) | mRCC - Axitinib | 18.37 | 95% Confidence Interval 14.03 to 24.15 | Months | |
| Overall Survival (OS) | MCL - Temsirolimus | 15.11 | 95% Confidence Interval 8.54 to 22.01 | Months | |
| Overall Survival (OS) | GIST - Sunitinib | 16.30 | 95% Confidence Interval 7.29 to 53.22 | Months | |
| Progression Free Survival (PFS) | mRCC - Temsirolimus | 3.91 | 95% Confidence Interval 3.45 to 4.63 | Months | |
| Progression Free Survival (PFS) | mRCC - Sunitinib | 6.93 | 95% Confidence Interval 6.24 to 8.25 | Months | |
| Progression Free Survival (PFS) | mRCC - Axitinib | 5.75 | 95% Confidence Interval 4.90 to 6.64 | Months | |
| Progression Free Survival (PFS) | MCL - Temsirolimus | 3.68 | 95% Confidence Interval 3.02 to 4.86 | Months | |
| Progression Free Survival (PFS) | GIST - Sunitinib | 10.32 | 95% Confidence Interval 3.58 to 12.94 | Months |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow11
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With mRCC, MCL or GIST | 1,520 | |
| Overall Study | Participants With mRCC | Participants With mRCC, MCL or GIST | 1,435 | |
| Overall Study | Participants With MCL | Participants With mRCC, MCL or GIST | 59 | |
| Overall Study | Participants With GIST | Participants With mRCC, MCL or GIST | 26 | |
| Overall Study | Participants With mRCC Who Received Temsirolimus | Participants With mRCC, MCL or GIST | 605 | |
| Overall Study | Participants With mRCC Who Received Sunitinib | Participants With mRCC, MCL or GIST | 702 | |
| Overall Study | Participants With mRCC Who Received Axitinib | Participants With mRCC, MCL or GIST | 237 | |
| Overall Study | Participants With MCL Who Received Temsirolimus | Participants With mRCC, MCL or GIST | 59 | |
| Overall Study | Participants With GIST Who Received Sunitinib | Participants With mRCC, MCL or GIST | 26 | |
| Overall Study | COMPLETED | Participants With mRCC, MCL or GIST | 289 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 participant flowAdverse events5,555
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 | mRCC - Temsirolimus | 78 | 605 | |
| other | Fatigue | General disorders | mRCC - Sunitinib | 144 | 702 | |
| other | Fatigue | General disorders | mRCC - Axitinib | 39 | 237 | |
| other | Fatigue | General disorders | MCL - Temsirolimus | 6 | 59 | |
| other | Fatigue | General disorders | GIST - Sunitinib | 3 | 26 | |
| other | Disease progression | General disorders | mRCC - Temsirolimus | 8 | 605 | |
| other | Disease progression | General disorders | mRCC - Sunitinib | 14 | 702 | |
| other | Disease progression | General disorders | mRCC - Axitinib | 8 | 237 | |
| other | Disease progression | General disorders | MCL - Temsirolimus | 0 | 59 | |
| other | Disease progression | General disorders | GIST - Sunitinib | 0 | 26 |
1 to 10 of 5,555Source ClinicalTrials.gov
See all 5,555 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | mRCC - Temsirolimus | 440 | 605 |
| Total, all-cause mortality | mRCC - Sunitinib | 420 | 702 |
| Total, all-cause mortality | mRCC - Axitinib | 163 | 237 |
| Total, all-cause mortality | MCL - Temsirolimus | 40 | 59 |
| Total, all-cause mortality | GIST - Sunitinib | 16 | 26 |
| Total, other adverse events | mRCC - Temsirolimus | 342 | 605 |
| Total, other adverse events | mRCC - Sunitinib | 485 | 702 |
| Total, other adverse events | mRCC - Axitinib | 148 | 237 |
| Total, other adverse events | MCL - Temsirolimus | 45 | 59 |
| Total, other adverse events | GIST - Sunitinib | 18 | 26 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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.
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