Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ixabepilone (Ixempra), Ixempra, azaepothilone B, BMS-247550, epothilone B lactam, Epothilone-B BMS 247550, NCS 710248, Neoadjuvant Treatment
Ixabepilone · 8 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.
Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery
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. |
| Ixabepilone/Trastuzumab/Carboplatin | EXPERIMENTAL | Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate |
| 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 |
| Trastuzumab | DRUG | Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52 |
| 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 oncology drug studied in advanced cancer, breast cancer, esophageal cancer, metastatic breast cancer, and solid tumors. It has been investigated in metastatic breast cancer, HER2-positive locally advanced breast cancer, and unspecified adult solid tumors. It is a small molecule developed by Bristol-Myers Squibb Company.
Ixabepilone targets tubulin proteins, specifically TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these targets. By binding tubulin, it interferes with microtubule function in cancer cells, which is the basis for its investigation across solid tumor and breast cancer settings.
Ixabepilone is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor associated with the clinical development program for this small molecule oncology agent.
Ixabepilone is in Phase 1 development based on its current clinical program. It is an investigational agent and is not described as approved. The trial record includes Phase 1 and Phase 2 studies, with the overall program listed at Phase 1.
Ixabepilone has been studied in trials including NCT01075100 in metastatic breast cancer, NCT00884676 in progressive advanced solid tumors, and NCT00821886 in HER2-positive locally advanced breast cancer. A further Phase 1 study, NCT00798252, evaluated brivanib alaninate with chemotherapeutic agents in advanced cancers.
Yes, Ixabepilone is also known as Ixempra. Ixempra is the brand name associated with ixabepilone, so searches for either name refer to the same Bristol-Myers Squibb oncology drug.