Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AEZS-108/ zoptarelin doxorubicin · 1 trial · 1 indication
Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact. The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died. A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated.
| Arm | Type | Description |
|---|---|---|
| AEZS-108 / zoptarelin doxorubicin | EXPERIMENTAL | 267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles |
| doxorubicin/ standard chemotherapy | ACTIVE_COMPARATOR | 60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles |
| Name | Type | Description |
|---|---|---|
| AEZS-108 / zoptarelin doxorubicin | DRUG | 267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles |
| doxorubicin | DRUG | 60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles |
Inclusion Criteria: 1. Women ≥ 18 years of age 2. Histologically confirmed endometrial cancer 3. Advanced (FIGO stage III or IV), recurrent or metastatic disease. 4. Measurable or non-measurable disease that has progressed since last treatment. 5. 5\. Patients with advanced, recurrent or metastatic...
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AEZS-108 is an investigational small molecule being studied for the treatment of endometrial cancer and ovarian cancer. It is a targeted therapy that has been evaluated in clinical trials for these gynecological tumors. The drug is still in clinical development and is not approved by the FDA.
AEZS-108 targets LHRH receptors, which are found on certain gynecological tumors. By binding to these receptors, the drug is designed to deliver its anticancer effect specifically to cancer cells that express LHRH receptors. This targeted approach is being studied in patients with LHRH receptor positive tumors.
AEZS-108 is being developed by COSCIENS Biopharma Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gynecological cancers. COSCIENS Biopharma Inc. is publicly traded under the ticker symbol CSCI.
AEZS-108 has completed a Phase 2 clinical trial and a Phase 3 clinical trial. The Phase 2 trial evaluated the drug in women with LHRH receptor positive gynecological tumors, while the Phase 3 trial studied it as a second-line therapy for endometrial cancer. The drug is investigational and not yet approved.
AEZS-108 has been studied in two completed clinical trials. The first, NCT00569257, was a Phase 2 trial in women with LHRH receptor positive ovarian and endometrial cancer. The second, NCT01767155, was a Phase 3 trial of zoptarelin doxorubicin (AEZS-108) as second-line therapy for endometrial cancer, enrolling 511 patients.
Yes, AEZS-108 is also known as zoptarelin doxorubicin. The Phase 3 clinical trial for endometrial cancer used the name zoptarelin doxorubicin (AEZS-108) to refer to the same drug. Both names refer to the same investigational compound being developed by COSCIENS Biopharma Inc.