Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pegylated liposomal doxorubicin (PLD)
Pegylated liposomal doxorubicin · 3 trials · 3 indications
TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ \& \>20 mm by clinical imaging (\>=10 mm with spiral CT scan). Non-target lesions were all other lesions.
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.
| Arm | Type | Description |
|---|---|---|
| Pegylated liposomal doxorubicin | EXPERIMENTAL | - |
| Capecitabine | ACTIVE_COMPARATOR | - |
| Caelyx, Docetaxel, Trastuzumab | EXPERIMENTAL | Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx. Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab. |
| Single Arm | EXPERIMENTAL | Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min. |
| Name | Type | Description |
|---|---|---|
| Pegylated liposomal doxorubicin (SCH 200746) | DRUG | pegylated liposomal doxorubicin (50 mg/m\^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity |
| Capecitabine | DRUG | capecitabine (1250 mg/m\^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity |
| Pegylated Liposomal Doxorubicin | DRUG | Stage 1: 25 subjects will be treated with Caelyx IV 30 mg/m\^2 on day 1, every 3 weeks Stage 2: 45 new patients will be treated at the recommended dose level (defined in the first step) on day 1, every 3 weeks. |
| Docetaxel | DRUG | Stage 1 and Stage 2: Docetaxel 60 mg/m2 IV as 1-hour infusion, on day 1, every 3 weeks. |
| Trastuzumab | DRUG | Stage 1 and Stage 2: 4 mg/kg IV 90-minute infusion loading dose. Then 2 mg/kg IV weekly during 6 cycles (18 weeks). |
| Carboplatin | DRUG | Subjects will receive carboplatin dosed to target AUC of 5 mg/mL.min, intravenously, on Day 1 of each 4-week cycle, after the Caelyx infusion, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy. |
Inclusion Criteria: * Patients must be female. * Patients must have metastatic disease of a cytological or histological confirmed breast cancer. * Patients must be 18 years or older. * Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST crite...
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Pegylated Liposomal Doxorubicin is used for treating ovarian neoplasms and breast cancer, including metastatic breast cancer. It is an oncology small molecule being studied in clinical trials for these conditions.
Pegylated Liposomal Doxorubicin is developed by Merck & Company, Inc., which trades under the ticker MRK on the stock exchange.
Pegylated Liposomal Doxorubicin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
Pegylated Liposomal Doxorubicin has been studied in completed trials including NCT00266799, a Phase 3 trial in metastatic breast cancer with 210 participants, NCT00687440, a Phase 2 trial in breast neoplasm with 27 participants, and NCT00780039, a Phase 2 trial in ovarian neoplasms with 58 participants.
Yes, Pegylated Liposomal Doxorubicin is also known as Pegylated liposomal doxorubicin (PLD). These names refer to the same drug.