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Also known as AN-152, doxorubicin-GnRH agonist conjugate AEZS-108, doxorubicin-LHRH agonist conjugate AEZS-108
AEZS-108 · 3 trials · 6 indications
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 |
| Arm I | EXPERIMENTAL | Patients receive doxorubicin-GnRH agonist conjugate AEZS-108 intravenously (IV) over 2 hours once every 21 days (21 days = 1 cycle). Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| 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 |
| AEZS-108 | DRUG | intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles |
| laboratory biomarker analysis | OTHER | Correlative study |
| questionnaire administration | OTHER | Correlative study |
| doxorubicin-GnRH agonist conjugate AEZS-108 | DRUG | Given IV |
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, also known as zoptarelin doxorubicin, is an investigational small molecule oncology drug being developed by COSCIENS Biopharma Inc. (ticker CSCI). It is being studied in women with gynecological cancers, specifically endometrial cancer and ovarian cancer. It has completed a Phase 3 trial and a Phase 2 trial.
AEZS-108 is being developed as a treatment for endometrial cancer, including as second line therapy. It has also been studied in ovarian cancer. The Phase 3 trial evaluated it in women with endometrial cancer, and a Phase 2 trial studied it in LHRH receptor positive gynecological tumors including ovarian and endometrial cancer.
AEZS-108 is being developed by COSCIENS Biopharma Inc., which trades under the ticker CSCI. The company is the sponsor of the clinical development program for zoptarelin doxorubicin in gynecological cancers.
AEZS-108 has completed a Phase 3 clinical trial and a Phase 2 clinical trial. It is an investigational drug and is not approved. The Phase 3 trial, NCT01767155, evaluated zoptarelin doxorubicin as second line therapy for endometrial cancer and has been completed.
AEZS-108 has been studied in two completed clinical trials. NCT01767155 was a Phase 3 trial of zoptarelin doxorubicin as second line therapy for endometrial cancer with 511 patients. NCT00569257 was a Phase 2 trial of AEZS-108 in women with LHRH receptor positive gynecological tumors, including ovarian and endometrial cancer, with 85 patients.
Yes, AEZS-108 is also known as zoptarelin doxorubicin. The two names refer to the same investigational drug, which is being developed by COSCIENS Biopharma Inc. for endometrial cancer and ovarian cancer. Clinical trial records use both names interchangeably.