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Also known as Custirsen, custirsen sodium
Custirsen, paclitaxel and carboplatin · 7 trials · 4 indications
Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.
Overall survival time is defined as the number of days from the date of randomization until the date of death from any cause. Participants who did not achieve the event (death) at the time of the analysis or who dropped out before completing the survival follow-up period will be censored at the date they were last known to be alive (i.e., right censored). Partial or missing dates of death or last contact were imputed.
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.
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.
The primary ECG variable and endpoint for this study is the time-matched change from baseline in QTcI method on day 7 at each time point. Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
The maximum peak concentration of paclitaxel after administration.
Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: \>= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.
| Arm | Type | Description |
|---|---|---|
| Custirsen + Docetaxel | EXPERIMENTAL | Custirsen: Three loading doses of custirsen 640 mg intravenously (IV) over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle. Docetaxel: 75 mg/m\^2 IV over 1 hour on Day 1 of every 21-day cycle. Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters to stop. |
| Docetaxel | ACTIVE_COMPARATOR | Docetaxel: 75 mg/m\^2 IV over 1 hour on Day 1 of every 21-day cycle. Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters to stop. |
| Cabazitaxel plus Custirsen | EXPERIMENTAL | cabazitaxel, prednisone, and custirsen sodium |
| Cabazitaxel | ACTIVE_COMPARATOR | cabazitaxel and prednisone |
| 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 |
| Group 1 | EXPERIMENTAL | Group 1: investigational product (custirsen) will receive: * 320 mg of custirsen + 5 mg of dexamethasone on day 1 * 480 mg of custirsen + 5 mg of dexamethasone on day 3 * 640 mg of custirsen + 3 mg of dexamethasone on day 5 * 640 mg of custirsen on day 7 under fasting conditions |
| Group 2 | PLACEBO_COMPARATOR | Group 2: placebo (normal saline) will receive: * placebo + 5 mg of dexamethasone on day 1 * placebo + 5 mg of dexamethasone on day 3 * placebo + 3 mg of dexamethasone on day 5 * placebo on day 7 under fasting conditions |
| Group 3 | ACTIVE_COMPARATOR | Group 3: positive control (moxifloxacin) will receive: * placebo + 5 mg of dexamethasone on day 1 * placebo + 5 mg of dexamethasone on day 3 * placebo + 3 mg of dexamethasone on day 5 * 400 mg of moxifloxacin + placebo (immediately after moxifloxacin administration) on day 7 under fasting conditions |
| Paclitaxel/carboplatin with custirsen | EXPERIMENTAL | Custirsen added to standard paclitaxel/carboplatin chemotherapy |
| Name | Type | Description |
|---|---|---|
| Custirsen | DRUG | - |
| Docetaxel | DRUG | - |
| 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 |
| 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. |
| Placebo | DRUG | Placebo (commercially available normal saline) will be administered iv using an infusion pump over a 2-hour period. |
| Moxifloxacin | DRUG | Moxifloxacin (400 mg) will be administered orally with 240 mL of room temperature still water. |
| Custirsen, paclitaxel and carboplatin | DRUG | Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle |
Inclusion Criteria: 1. Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IV per American Joint Committee on Cancer 7th edition Tumor size, lymph Nodes affected, Metastases staging) non-small cell lung cancer (NSCLC). 2. Males or females ≥ 18...
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Custirsen, paclitaxel and carboplatin is an investigational combination cancer treatment that pairs the RNA therapy custirsen with the chemotherapy agents paclitaxel and carboplatin. It has been studied in cancer indications including non-small cell lung cancer and prostate cancer. The combination remains in clinical development and is not an approved therapy.
Custirsen targets clusterin, encoded by the CLU gene. It is an antisense inhibitor designed to reduce clusterin production. Clusterin is a protein associated with treatment resistance in cancer, so inhibiting it is intended to make tumor cells more responsive to chemotherapy. Custirsen is given alongside chemotherapy agents such as paclitaxel and carboplatin.
The combination is being developed by Achieve Life Sciences, Inc., which trades under the ticker ACHV. The company is the sponsor behind the custirsen clinical program, including studies that combine custirsen with chemotherapy regimens such as paclitaxel and carboplatin.
The custirsen program is at the Phase 1 stage overall, with Phase 3 studies also conducted in specific cancer indications. Custirsen is investigational and has not been approved by the FDA. Three completed trials are recorded for the program, with no active trials at this time.
Completed studies include NCT01497470, a Phase 1 trial in cancer patients examining whether custirsen affects blood levels of paclitaxel when given together. Other completed trials include NCT01630733 in advanced non-small cell lung cancer, NCT01578655 in prostate cancer, and NCT01874561, a Phase 1 cardiac repolarization study in healthy volunteers.
Yes. Custirsen is also known as custirsen sodium and by the research code OGX-011. The names custirsen, custirsen sodium, and OGX-011 refer to the same antisense compound. Earlier development also included a custirsen and mitoxantrone combination, which is the same agent studied with a different chemotherapy partner.