Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
liposomal doxorubicin · 1 trial · 1 indication
Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy | ACTIVE_COMPARATOR | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m\^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks \[q3w\]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. |
| Chemotherapy + Bevacizumab | EXPERIMENTAL | Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks |
| liposomal doxorubicin | DRUG | 40mg/m2 iv every 4 weeks |
| paclitaxel | DRUG | 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle |
| topotecan | DRUG | 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle |
Inclusion Criteria: * female patients, \>/=18 years of age * epithelial ovarian, fallopian tube or primary peritoneal cancer * platinum-resistant disease (disease progression within \<6 months of platinum therapy) * EOCG performance status of 0-2 Exclusion Criteria: * non-epithelial tumours * ova...
Top 20 of 59 competitors
Liposomal doxorubicin is a small molecule chemotherapy being studied for the treatment of ovarian cancer. It is being evaluated in combination with other therapies for patients with platinum-resistant ovarian cancer. The drug is currently in Phase 3 clinical development and is not yet approved for this indication.
Liposomal doxorubicin is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ovarian cancer.
Liposomal doxorubicin is in Phase 3 clinical development for ovarian cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Liposomal doxorubicin was studied in the AURELIA trial, registered as NCT00976911. This Phase 3 study evaluated the addition of bevacizumab to chemotherapy in patients with platinum-resistant ovarian cancer. The trial enrolled 361 female participants aged 18 years and older and has been completed.
Liposomal doxorubicin is a formulation of the chemotherapy drug doxorubicin encapsulated in liposomes. This formulation is designed to alter the drug's distribution in the body. In the context of the AURELIA trial, it was used as part of the chemotherapy backbone for ovarian cancer treatment.