Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
custirsen/mitoxantrone · 2 trials · 1 indication
Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.
Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE.
| Arm | Type | Description |
|---|---|---|
| Custirsen, Docetaxel, Prednisone | EXPERIMENTAL | Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. |
| Docetaxel, Prednisone | ACTIVE_COMPARATOR | Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. |
| OGX-011 / mitoxantrone/prednisone | EXPERIMENTAL | OGX-011 / mitoxantrone/prednisone: OGX-011 administered in combination with mitoxantrone and prednisone |
| OGX-011/docetaxel/prednisone | EXPERIMENTAL | OGX-011/docetaxel/prednisone: OGX-011 administered in combination with docetaxel and prednisone |
| Name | Type | Description |
|---|---|---|
| Custirsen | DRUG | - |
| Docetaxel | DRUG | - |
| Prednisone | DRUG | - |
| Dexamethasone | DRUG | Dexamethasone 8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention. |
| custirsen (OGX-011)/mitoxantrone | DRUG | All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to-1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was administered IV on Day 1 of each cycle at a planned dose of 12 mg/m² infused over 30 minutes. Patients could receive a maximum of 9 cycles of treatment. |
| custirsen (OGX-011)/docetaxel | DRUG | All subjects began treatment with oral prednisone (5 mg twice daily, 10 mg/day) continued through completion of the final treatment cycle. Three IV administrations of OGX-011 (640 mg) were given as 2 hr infusions during the loading dose period (Days-9 to -1). Subjects were premedicated with either ibuprofen (400 mg) or acetaminophen (650 mg) 30 to 60 minutes prior to and every 4-6 hours for 24 hours following each of the three doses of OGX-011 during the loading dose period only. After the loading dose period, OGX-011 was given weekly on Days 1, 8, and 15 of each 21 day cycle. Docetaxel was administered IV on Day 1 of each cycle at a planned dose of 75 mg/m² infused over 60 minutes. Patients could receive a maximum of 9 cycles of treatment. |
Inclusion Criteria * Age ≥ 18 years on the date of consent. * Histological or cytological diagnosis of adenocarcinoma of the prostate. * Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan. * Systemic chemotherapy indicated due to progression while on or after androgen ablative th...
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Custirsen is an investigational small molecule being studied for use in non-small cell lung cancer, prostate cancer, and other cancers. It has also been evaluated in a study of cardiac conduction and repolarization. Custirsen is not approved and remains in clinical development.
Custirsen is being developed by Achieve Life Sciences, Inc., a company traded on the NASDAQ under the ticker symbol ACHV. The drug is currently in Phase 1 clinical development.
Custirsen is in Phase 1 clinical development. It has completed two Phase 1 trials and one Phase 3 trial, but it is not approved and remains investigational.
Custirsen has completed several clinical trials. NCT00138658 studied Custirsen with gemcitabine and a platinum-based regimen in stage IIIB/IV non-small cell lung cancer. NCT01497470 examined its effect on paclitaxel blood levels in cancer patients. NCT01630733 was a Phase 3 study in advanced or metastatic non-small cell lung cancer. NCT01874561 evaluated its effect on cardiac repolarization.
Yes, Custirsen is also known as OGX-011. In clinical trials, it has been referred to by both names, including in studies of non-small cell lung cancer.