Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as sunitinib malate, SU011248, Sunitinib (Sutent), Sunitinib, Pemetrexed, Sunitinib, Pemetrexed, Cisplatin, Carboplatin, Sunitinib malate (SU011248), Sunitinib and Bortezomib, SU011248 capsule
sunitinib · 41 trials · 23 indications
DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by blinded independent central review (BICR) or investigator assessment for respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for remainder of follow-up period unless the participant had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.
DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.
Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.
PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.
Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Estimated steady-state maximum plasma concentration (Cmax,ss) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.
Estimated area under the plasma concentration versus time curve from time zero to 24 hours post dose (AUC24) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.
SU012662 is the metabolite of Sunitinib. Oral clearance (CL/F) is a quantitative measure of the rate at which a drug substance is removed from the blood (CL) normalized by the oral bioavailability of the drug (F). Summarized data for all time points was reported.
SU012662 is the metabolite of Sunitinib.
SU012662 is the metabolite of Sunitinib.
AUC(0-8) was defined as area under the plasma concentration time-curve from time zero to 8 hours post dose. SU012662 is the metabolite of Sunitinib.
CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Number 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). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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.
Number of subjects with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ≥ 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of ≥ 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Number of patients with objective response: confirmed CR or confirmed PR according to RECIST. 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. To be assigned a status of PR or CR, changes in tumor measurements in patients with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-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 associated to a non-progressive disease response for the non target lesions.
Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. 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.
Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as \>= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.
The incidence of DLTs assessed during the first cycle (21 days).
A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng\*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.
Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
Mean AUC24\_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.
PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.
Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).
Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).
Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662).
Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662).
SU-011248 Clearance in the subjects enrolled in Phase 1. Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL).
Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1. Rac was the ratio of Day 28 to Day 1.
Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)\>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Children with GIST | EXPERIMENTAL | children ages 6yrs-\<18yrs |
| Young adults with GIST | EXPERIMENTAL | young adults ages 18yrs-\<21 yrs |
| Sunitinib arm | EXPERIMENTAL | - |
| Sunitinib | EXPERIMENTAL | - |
| SUNITINIB MALATE. | EXPERIMENTAL | Sunitinib malate starting dose 37.5 mg daily continuous daily schedule |
| SU-011248 capsule | EXPERIMENTAL | - |
| SU011248 (sunitinib) | EXPERIMENTAL | Single-arm study |
| CDD | EXPERIMENTAL | - |
| 2/1 | EXPERIMENTAL | - |
| Single arm | EXPERIMENTAL | SU011248 \[sunitinib\] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle. 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion |
| SU011248 | EXPERIMENTAL | 25 , 50 or 75 mg/day of SU011248 |
| Name | Type | Description |
|---|---|---|
| Sunitinib malate | DRUG | sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent. |
| Placebo | OTHER | Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent |
| erlotinib | DRUG | plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity |
| sunitinib | DRUG | Sunitinib 37.5 mg daily by oral capsules in a continuous regimen |
| Taxotere | DRUG | Docetaxel 100 mg/m2 every 3 weeks in the comparator arm |
| Sunitinib + Capecitabine | DRUG | Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. |
| Capecitabine | DRUG | Capecitabine administered orally at a starting dose of 2500 mg/m\^2 per day \[1250 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily. |
| paclitaxel | DRUG | Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity. |
| bevacizumab | DRUG | Bevacizumab 10 mg/kg IV every 2 weeks. |
| SU011248 | DRUG | 50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug. |
| sunitinib malate dose escalation | DRUG | sunitinib starting dose will be 15mg/m\^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2). |
| FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) | DRUG | FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
| Sunitinib (SU011248) | DRUG | Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity. |
| SU011248/Trastuzumab | DRUG | SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol. |
| Chemotherapy | DRUG | The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below. 1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks 2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles 3. Docetaxel - 75-100 mg/m2 every 3 weeks 4. Paclitaxel - 175-200 mg/m2 every 3 weeks 5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments. 6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248. |
| SU011248 capsule | DRUG | 50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops |
| carboplatin | DRUG | AUC of 6 mg\*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices. |
| SU011248 (sunitinib) | DRUG | 37.5 mg/day, oral, continuous daily dosing |
| Sunitinib and Bortezomib | DRUG | 50 mg/m2, IV (in the vein)on day 5 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops |
| Sunitinib, Pemetrexed | DRUG | Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity. |
| 5-fluorouracil | DRUG | 5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
| cisplatin | DRUG | Cisplatin is given 80 mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
| oxaliplatin | DRUG | Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. |
| sunitinib + mFOLFOX6 | DRUG | 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2) |
| S-1 | DRUG | S-1 80 mg/m2 on days 1-21 of each 28 day cycle |
| Sunitinib, Pemetrexed, Cisplatin, Carboplatin | DRUG | Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg\*min/mL until progression or unacceptable toxicity. |
| Sunitinib (Sutent) | DRUG | Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision |
| Docetaxel | DRUG | Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks). |
| Prednisone | DRUG | Prednisone Phase1/2 - 5 mg twice a day (BID), oral. |
| sunitinib + FOLFOX | DRUG | 37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2) |
| Sunitinib malate (SU011248) | DRUG | SU011248 |
Inclusion Criteria: * High risk renal cancer per modified UISS criteria * Eastern Cooperative Oncology Group (ECOG) 0-2 * predominant clear cell histology * No prior anti-cancer treatment * Kidney tumor has been removed * No evidence of macroscopic disease following surgery Exclusion Criteria: * ...
SU011248, also known as sunitinib, is an investigational small molecule being studied for the treatment of several cancers, including metastatic breast cancer, renal cell carcinoma, prostate cancer, colorectal cancer, and gastrointestinal stromal tumor. It is currently in Phase 2 clinical development for oncology indications.
SU011248 is a kinase inhibitor that targets CSF1R, KIT, FLT1, KDR, FLT4, and PDGFRA. By inhibiting these receptors, it interferes with signaling pathways involved in tumor growth and angiogenesis.
SU011248 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.
SU011248 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in various cancer indications.
SU011248 has been studied in four completed clinical trials, including NCT00078000, NCT00174434, NCT00243503, and NCT00246571. These trials evaluated the drug in patients with metastatic breast cancer, both as a single agent and in combination with other therapies such as paclitaxel and trastuzumab.
Yes, SU011248 is also known as sunitinib. Both names refer to the same investigational drug being developed by Pfizer for the treatment of various cancers.