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cabazitaxel · 1 trial · 1 indication
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.
| Arm | Type | Description |
|---|---|---|
| Cabazitaxel plus Custirsen | EXPERIMENTAL | cabazitaxel, prednisone, and custirsen sodium |
| Cabazitaxel | ACTIVE_COMPARATOR | cabazitaxel and prednisone |
| Name | Type | Description |
|---|---|---|
| cabazitaxel | DRUG | Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles |
| prednisone | DRUG | Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles |
| custirsen sodium | DRUG | Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles |
Inclusion Criteria: * Histological or cytological diagnosis of adenocarcinoma of the prostate * Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan * Previous first-line treatment for CRPC with a docetaxel-containing regimen * Current progressive disease * Increasing serum PS...
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Cabazitaxel is a small molecule oncology drug being studied for the treatment of prostate cancer. It is currently in Phase 3 clinical development as a second-line chemotherapy option. The drug is being evaluated in combination with prednisone, either alone or with custirsen, for patients with prostate cancer.
Cabazitaxel is a small molecule that belongs to the taxane class of chemotherapy drugs. It works by interfering with microtubule function, which is essential for cell division, thereby inhibiting cancer cell growth and proliferation. This mechanism makes it effective in treating prostate cancer.
Cabazitaxel is being developed by Achieve Life Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACHV. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with prostate cancer.
Cabazitaxel is currently in Phase 3 clinical development for the treatment of prostate cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will determine whether the drug can proceed to regulatory submission.
Cabazitaxel has one completed Phase 3 clinical trial with the identifier NCT01578655. This trial compared cabazitaxel and prednisone alone or in combination with custirsen for second-line chemotherapy in prostate cancer. The study enrolled 630 male participants across multiple countries, including the United States, Australia, Canada, and several European nations.
Cabazitaxel is a distinct chemotherapy agent used in prostate cancer, and it is not the same as other treatments like docetaxel or androgen deprivation therapy. It is a taxane derivative that works by inhibiting microtubule function. The drug is being studied as a second-line option for patients who have progressed after initial chemotherapy.