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Also known as Cabazitaxel-XRP6258 (3-week cycle)
Cabazitaxel XRP6258 · 4 trials · 6 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).
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 |
|---|---|---|
| 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. |
| 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 (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. |
| 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: * 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 oncology drug developed by Sanofi (ticker SNY). It has been studied in gastric cancer, malignant neoplasm, non-small cell lung cancer (NSCLC), and prostate cancer. It is a tubulin inhibitor that has been evaluated in Phase 1 and Phase 2 clinical trials.
Cabazitaxel XRP6258 has been studied in several cancer types, including gastric cancer, malignant neoplasm, non-small cell lung cancer (NSCLC), and prostate cancer. Clinical trials have evaluated it in metastatic castrate-resistant prostate cancer, advanced gastric cancer after prior chemotherapy, and advanced NSCLC.
Cabazitaxel XRP6258 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, which is the basis for its evaluation as an anticancer agent.
Cabazitaxel XRP6258 is developed by Sanofi, which trades under the ticker SNY. Sanofi has sponsored the clinical trials evaluating this small molecule tubulin inhibitor across multiple cancer indications, including prostate cancer, gastric cancer, and non-small cell lung cancer.
Cabazitaxel XRP6258 is in clinical development, with trials conducted in Phase 1 and Phase 2. It is investigational and has not been approved by the FDA. The completed studies include a Phase 2 trial in advanced non-small cell lung cancer and several Phase 1 trials in other cancer types.
Cabazitaxel XRP6258 has been evaluated in completed trials including NCT01527929, a pharmacokinetics and safety study in cancer patients with renal impairment; NCT01511536, a Phase 1 study with abiraterone acetate in metastatic castrate-resistant prostate cancer; NCT01497964 in advanced gastric cancer; and NCT01438307, a Phase 2 study in advanced NSCLC.
Yes. Cabazitaxel XRP6258 and Cabazitaxel-XRP6258 refer to the same drug. The name is also written as Cabazitaxel-XRP6258 (3-week cycle), which describes the dosing schedule used in some studies. All of these names identify the same Sanofi compound.