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Cabazitaxel-XRP6258 · 1 trial · 3 indications
The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).
| Arm | Type | Description |
|---|---|---|
| Schedule A | EXPERIMENTAL | Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258. Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases. |
| Schedule B | EXPERIMENTAL | Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A. Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases. |
| Name | Type | Description |
|---|---|---|
| Cabazitaxel-XRP6258 (3-week cycle) | DRUG | Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator. |
| Cabazitaxel-XRP6258 (5-week cycle) | DRUG | Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator. |
Inclusion Criteria: * Histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified) * Subjects who have failed first line chemotherapy (platinum doublets or non- platinum doublets \[previous taxane exposure is allowed\]) for Stage IV NSCLC. * Measurable disease as def...
Cabazitaxel XRP6258 is an investigational small molecule being studied for gastric cancer, non-small cell lung cancer (NSCLC), prostate cancer, and neoplasm malignant. It is developed by Sanofi (SNY) and is currently in Phase 1 clinical development for these oncology indications.
Cabazitaxel XRP6258 is a taxane derivative that works by stabilizing microtubules, which disrupts cell division and leads to cancer cell death. This mechanism is typical of taxane chemotherapy agents used in oncology.
Cabazitaxel XRP6258 is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.
Cabazitaxel XRP6258 is in Phase 1 clinical development. While some completed trials were Phase 2, the overall development stage is Phase 1, and the drug is investigational, meaning it is not yet approved by regulatory authorities.
Cabazitaxel XRP6258 has been studied in several completed trials, including NCT01438307 for advanced non-small cell lung cancer, NCT01497964 for advanced gastric cancer, NCT01511536 for metastatic prostate cancer, and NCT01527929 for cancer patients with renal impairment.
Cabazitaxel XRP6258 is a code name for cabazitaxel, a chemotherapy drug. The trials listed use both names interchangeably, indicating they refer to the same compound being investigated for various cancers.