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Cabazitaxel XRP6258 · 3 trials · 3 indications
MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting \>7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.
Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Normal renal function - Cabazitaxel administered once every 3 weeks |
| Cohort B | EXPERIMENTAL | Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks |
| Cohort C | EXPERIMENTAL | Severe renal dysfunction - Cabazitaxel administered once every 3 weeks |
| Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg | EXPERIMENTAL | Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. |
| Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | EXPERIMENTAL | Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. |
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | EXPERIMENTAL | Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m\^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal. |
| Cabazitaxel | EXPERIMENTAL | Cabazitaxel, several dosages |
| Name | Type | Description |
|---|---|---|
| Cabazitaxel XRP6258 | DRUG | Pharmaceutical form: solution for infusion Route of administration: intravenous |
| Abiraterone acetate | DRUG | Pharmaceutical form:tablets Route of administration: oral |
| Prednisone 5 mg | DRUG | Route of administration: oral |
Inclusion criteria : * Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator. * Eastern Coop...
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.