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Also known as AEZS-108, doxorubicin-LHRH agonist conjugate AEZS-108
doxorubicin-GnRH agonist conjugate 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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Doxorubicin-GnRH agonist conjugate AEZS-108 is an investigational small molecule oncology drug being developed by COSCIENS Biopharma Inc. for prostate cancer. It is a conjugate that pairs doxorubicin with a GnRH agonist. It has been studied in Phase 1 clinical development in patients with metastatic hormone-resistant prostate cancer.
Doxorubicin-GnRH agonist conjugate AEZS-108 has been studied for prostate cancer, specifically metastatic hormone-resistant prostate cancer, recurrent prostate cancer, and Stage IV prostate cancer. The Phase 1 trial enrolled men aged 18 years and older in the United States. It is an investigational agent and is not an approved treatment.
Doxorubicin-GnRH agonist conjugate AEZS-108 is developed by COSCIENS Biopharma Inc., which trades under the ticker CSCI. The company sponsored the Phase 1 study of the agent in metastatic hormone-resistant prostate cancer.
Doxorubicin-GnRH agonist conjugate AEZS-108 is in Phase 1 development. One Phase 1 trial has been conducted, and it is now completed. The drug remains investigational and has not been approved for any indication.
Doxorubicin-GnRH agonist conjugate AEZS-108 was evaluated in one Phase 1 trial, NCT01240629, titled Doxorubicin-GnRH Agonist Conjugate AEZS-108 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer. The trial enrolled 43 patients in the United States and is completed. It was an uncontrolled study without randomization or blinding.
Doxorubicin-GnRH agonist conjugate AEZS-108 is a small molecule conjugate that combines doxorubicin with a GnRH agonist. The GnRH agonist component is designed to direct the agent toward GnRH receptor-expressing cells, delivering the doxorubicin payload to prostate cancer cells that express the receptor.