Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ixabepilone · 7 trials · 7 indications
The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.
Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive \[ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-\]) and ER-/PR-HER2-, separately). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.
Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 \[log2 normalized intensity units\], respectively (corresponding to prevalence rates of 43.3% and 44.3%).
For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.
While on the drug combination, patients will be seen in the clinic every 3 weeks. These visits will assess the safety and tolerablility of the drug regimen. The drug combination continues until disease progression or unacceptable toxicity. When one of those two events occurs, the patient enters the followup phase. During the followup phase, the patient will return to the clinic every 4 weeks until drug-related toxicities resolve.
| Arm | Type | Description |
|---|---|---|
| Doxorubicin/cyclophosphamide, ixabepilone | EXPERIMENTAL | Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by ixabepilone at 40 mg/m2 given for 4 cycles of 21 days each. |
| Doxorubicin/cyclophosphamide, paclitaxel | ACTIVE_COMPARATOR | Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered for 4 cycles of 21 days each, followed by paclitaxel at 80 mg/m2 weekly for 12 weeks. |
| Weekly Ixabepilone +carboplatin | EXPERIMENTAL | Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle. |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Schedule A | EXPERIMENTAL | Schedule A: Ixabepilone - Weekly for 3 weeks each cycle (Days 1, 8 and 15) For both Schedules A and B, Sunitinib daily, orally, starting on Day 8 of Cycle 1 |
| Schedule B | EXPERIMENTAL | Ixabepilone - Day 1 of each 3-week cycle For both Schedules A and B, Sunitinib daily, orally, starting on Day 8 of Cycle 1. |
| Arm A (Capecitabine + Brivanib alaninate) | EXPERIMENTAL | - |
| Arm B (Doxorubicin + Brivanib alaninate) | EXPERIMENTAL | - |
| Arm C (Ixabepilone + Brivanib alaninate) | EXPERIMENTAL | - |
| Arm D (Docetaxel + Brivanib alaninate) | EXPERIMENTAL | - |
| Arm E (Paclitaxel + Brivanib alaninate) | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily. All participants will receive the study drugs at a baseline dose. If the side effects are minimal and tolerable, the next cycle of study drugs will be given at same dosage. If side effects are intolerable, then the dose will be lowered. |
| Name | Type | Description |
|---|---|---|
| Doxorubicin | DRUG | Doxorubicin 60 mg/m2 |
| Cyclophosphamide | DRUG | Cyclophosphamide 600 mg/m2 |
| Ixabepilone (Ixempra) | DRUG | Ixabepilone 40 mg/m2 |
| Paclitaxel (Taxol) | DRUG | Paclitaxel 80 mg/m2 |
| Ixabepilone | DRUG | 20 mg/m2 on Days 1 and 8 |
| Carboplatin | DRUG | carboplatin AUC=2.5 on Days 1 and 8 |
| Paclitaxel | DRUG | Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks |
| Sunitinib | DRUG | For both Schedules A and B, daily, orally, starting on Day 8 of Cycle 1 |
| Capecitabine | DRUG | Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression |
| Docetaxel | DRUG | IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression |
| Brivanib alaninate | DRUG | Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression |
| Dasatinib | DRUG | by mouth once daily |
Inclusion Criteria: 1. Female patients greater than or equal to18 years of age. 2. Histologically confirmed invasive unilateral breast cancer (regardless of histology). 3. Early-stage breast cancer, defined as: * Node-positive disease: \>0.2-mm metastasis in at least one lymph node (pN1mipN...
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Ixabepilone is an investigational small molecule being studied for the treatment of solid tumors, advanced cancer, breast cancer, unspecified adult solid tumors, esophageal cancer, and metastatic breast cancer. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.
Ixabepilone is a small molecule that targets microtubules, stabilizing them and disrupting cell division. This mechanism is being evaluated in clinical trials for its potential to treat various cancers, including breast cancer and advanced solid tumors.
Ixabepilone is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
Ixabepilone is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of solid tumors, advanced cancer, and breast cancer.
Ixabepilone has been studied in several completed clinical trials, including NCT00455533, a Phase 2 study in early stage breast cancer; NCT00789581, a Phase 3 trial in triple negative breast cancer; NCT00798252, a Phase 1 study in advanced cancer; and NCT00884676, a Phase 1 trial in advanced solid tumors.
Ixabepilone is also known as Ixempra. In clinical trials, it has been referred to by both names, such as in the study titled 'A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer'.