Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sunitinib
SU011248 · 11 trials · 7 indications
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).
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.
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
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.
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.
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.
PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.
| Arm | Type | Description |
|---|---|---|
| B | PLACEBO_COMPARATOR | - |
| A | ACTIVE_COMPARATOR | - |
| SU-011248 capsule | EXPERIMENTAL | - |
| SU011248 (sunitinib) | EXPERIMENTAL | Single-arm study |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | 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. |
| 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. |
| 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 |
| SU011248 (sunitinib) | DRUG | 37.5 mg/day, oral, continuous daily dosing |
| 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. |
| Paclitaxel | DRUG | Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first. |
Key Inclusion Criteria: * Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent * Failed Gleevec treatment or intolerant to Gleevec therapy Key Exclusion Criteria: * Treatment with any chemotherapy, chemoembolizati...
SU011248, also known as Sunitinib, is an investigational small molecule being studied for use in oncology. It is being evaluated for the treatment of several cancers, including prostate cancer, breast cancer, renal cell carcinoma, colorectal cancer, and gastrointestinal stromal tumors (GIST). The drug is currently in Phase 2 clinical development.
SU011248, also known as Sunitinib, is a small molecule kinase inhibitor, belonging to the -tinib class of drugs. It works by targeting and inhibiting kinase enzymes, which play a role in cancer cell growth and proliferation. This mechanism is being studied across multiple oncology indications, including renal cell carcinoma and gastrointestinal stromal tumors.
SU011248, also known as Sunitinib, is being developed by Pfizer, Inc., a company publicly traded under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types, including gastrointestinal stromal tumors and prostate cancer.
SU011248, also known as Sunitinib, is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in multiple oncology indications, including colorectal cancer and gastrointestinal stromal tumors, with four completed clinical trials to date.
SU011248, also known as Sunitinib, has been studied in four completed clinical trials. These include NCT00075218, a Phase 3 trial in gastrointestinal stromal tumors with 361 participants; NCT00077987, a Phase 2 trial in metastatic colorectal cancer with 84 participants; NCT00137436, a Phase 1 trial in prostate cancer with 93 participants; and NCT00137449, a Phase 2 trial in gastrointestinal stromal tumors with 60 participants.
Yes, SU011248 is the same as Sunitinib. The drug is known by both names, with Sunitinib being the more common name. It is being developed by Pfizer, Inc. for the treatment of various cancers, including renal cell carcinoma, breast cancer, and gastrointestinal stromal tumors.