Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
custirsen · 3 trials · 2 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.
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.
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. |
| 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 |
| Name | Type | Description |
|---|---|---|
| Custirsen | DRUG | - |
| Docetaxel | DRUG | - |
| 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 sodium | DRUG | Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused intravenously on Day 1 of this 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle = 21 days) |
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 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.