A Phase 3 interventional study of Sorafenib and temsirolimus (Torisel) in Renal Cell Carcinoma, sponsored by Pfizer. Completed at 128 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-21.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 512 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.
Exclusion Criteria:
Active ketonuria, secondary to poorly controlled diabetes mellitus
Drug: Sorafenib
Drug: temsirolimus (Torisel)
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
Progression-Free Survival (PFS)
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
Time frame: Baseline up to 24 Months
Progression Free Survival (PFS) by Investigator Assessment
Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
Time frame: Baseline up to 24 Months
Percentage of Participants With Tumor Response
Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time frame: Baseline up to 24 Months
Overall Survival (OS)
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time frame: Baseline to date of death from any cause (up to 24 months)
Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment
PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
Time frame: Weeks 12, 24, and 36
Duration of Response (DR)
Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.
Time frame: Baseline up to 24 Months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline up to 24 months
| Milestone | Temsirolimus | Sorafenib |
|---|---|---|
| Started | 259 | 253 |
| Completed | 0 | 0 |
| Not completed | 259 | 253 |
| Withdrew: Not meeting study criteria | 0 | 1 |
| Withdrew: Investigator request | 2 | 1 |
| Withdrew: Death | 189 | 170 |
| Withdrew: Discontinuation of study by sponsor | 42 | 59 |
| Withdrew: Lost to follow-up | 4 | 7 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Withdrawal by subject | 15 | 15 |
| Withdrew: Other | 5 | 0 |
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
| months | Temsirolimus | Sorafenib |
|---|---|---|
| Progression-Free Survival (PFS) | 4.28 (4.01 to 5.43) | 3.91 (2.80 to 4.21) |
Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.
| months | Temsirolimus | Sorafenib |
|---|---|---|
| Progression Free Survival (PFS) by Investigator Assessment | 5.43 (4.24 to 5.86) | 4.14 (3.26 to 5.36) |
Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
| percentage of participants | Temsirolimus | Sorafenib |
|---|---|---|
| Percentage of Participants With Tumor Response | 7.7 (4.8 to 11.7) | 7.9 (4.9 to 11.9) |
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
| months | Temsirolimus | Sorafenib |
|---|---|---|
| Overall Survival (OS) | 12.27 (10.13 to 14.80) | 16.64 (13.55 to 18.72) |
PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.
| percentage of participants | Temsirolimus | Sorafenib |
|---|---|---|
| Baseline to Week 12 | 31.2 | 36.7 |
| Week 13 to Week 24 | 20.9 | 20.1 |
| Week 25 to Week 36 | 12.3 | 11.2 |
Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.
| months | Temsirolimus | Sorafenib |
|---|---|---|
| Duration of Response (DR) | 8.26 (6.71 to 10.36) | 6.96 (4.18 to 17.50) |
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
| participants | Temsirolimus | Sorafenib |
|---|---|---|
| Serious AE | 103 | 86 |
| Any AE | 248 | 251 |
Collected over 5.3 years approximately. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Temsirolimus | — | 104/249 (41.8%) | 243/249 (97.6%) |
| Sorafenib | — | 87/252 (34.5%) | 249/252 (98.8%) |
| Event | Temsirolimus | Sorafenib |
|---|---|---|
| General physical health deteriorationGeneral disorders | 8/249 | 9/252 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 7/249 | 8/252 |
| Abdominal painGastrointestinal disorders | 7/249 | 1/252 |
| PyrexiaGeneral disorders | 7/249 | 4/252 |
| PneumoniaInfections and infestations | 7/249 | 7/252 |
| DehydrationMetabolism and nutrition disorders | 7/249 | 6/252 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 7/249 | 5/252 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 7/249 | 0/252 |
| VomitingGastrointestinal disorders | 6/249 | 4/252 |
| AnaemiaBlood and lymphatic system disorders | 5/249 | 4/252 |
| Event | Temsirolimus | Sorafenib |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 74/249 | 156/252 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 11/249 | 131/252 |
| RashSkin and subcutaneous tissue disorders | 104/249 | 87/252 |
| FatigueGeneral disorders | 99/249 | 84/252 |
| Decreased appetiteMetabolism and nutrition disorders | 76/249 | 94/252 |
| CoughRespiratory, thoracic and mediastinal disorders | 85/249 | 57/252 |
| AnaemiaBlood and lymphatic system disorders | 83/249 | 34/252 |
| NauseaGastrointestinal disorders | 81/249 | 71/252 |
| AlopeciaSkin and subcutaneous tissue disorders | 5/249 | 78/252 |
| Mucosal inflammationGeneral disorders | 74/249 | 35/252 |
| Age Continuous(years) | Temsirolimus | Sorafenib | Total |
|---|---|---|---|
| Mean | 59.96 ± 10.20 | 59.74 ± 10.33 | 59.85 ± 10.25 |
| Sex: Female, Male(Participants) | Temsirolimus | Sorafenib | Total |
|---|---|---|---|
| Female | 66 | 61 | 127 |
| Male | 193 | 192 | 385 |
Showing the first 100 of 128 sites across 20 countries.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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