Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DOXIL
DOXIL/CAELYX Treatment Sequence AB · 4 trials · 6 indications
Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
Cmax is defined as the maximum observed analyte concentration.
Tmax is defined as the actual sampling time to reach maximum observed analyte concentration.
AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of the Area Under the Curve (AUC) last and AUC(last)/lambda, in which AUC(last) is the last observed quantifiable concentration.
| Arm | Type | Description |
|---|---|---|
| Thalidomide + dexamethasone | ACTIVE_COMPARATOR | - |
| Thalidomide + dexamethasone + DOXIL | EXPERIMENTAL | - |
| DOXIL and docetaxel combination therapy | EXPERIMENTAL | DOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. |
| Docetaxel monotherapy | ACTIVE_COMPARATOR | Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle |
| Sequence AB | EXPERIMENTAL | Twenty-one participants will receive DOXIL/CAELYX reference product in Cycle 1 and DOXIL/CAELYX test product in Cycle 2. Each cycle will be separated by 28 days. |
| Sequence BA | EXPERIMENTAL | Twenty-one participants will receive DOXIL/CAELYX test product in Cycle 1 and DOXIL/CAELYX reference product in Cycle 2. Each cycle will be separated by 28 days. |
| Treatment A: DOXIL/CAELYX (doxorubicin) | EXPERIMENTAL | 50 mg/m2 of doxorubicin manufactured at the current site of manufacturing administered by IV infusion over 90 minutes on Day 1 |
| Treatment B: DOXIL/CAELYX (doxorubicin) | EXPERIMENTAL | 50 mg/m2 of doxorubicin manufactured at the new site of manufacturing (test product) administered by IV infusion over 90 minutes on Day 1 |
| Name | Type | Description |
|---|---|---|
| Thalidomide | DRUG | Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles. |
| Dexamethasone | DRUG | Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20. |
| DOXIL | DRUG | DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1. |
| Docetaxel | DRUG | Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle |
| DOXIL/CAELYX reference product (Treatment A) | DRUG | Participants will receive DOXIL/CAELYX reference product 50 mg/m2 as an intravenous (into a vein) infusion over 90 minutes on Day 1. |
| DOXIL/CAELYX test product (Treatment B) | DRUG | Participants will receive DOXIL/CAELYX test product 50 mg/m2 as an intravenous infusion over 90 minutes on Day 1. |
| DOXIL/CAELYX (doxorubicin) Treatment Sequence AB | DRUG | Cycle 1 = Treatment A, Cycle 2 = Treatment B |
| DOXIL/CAELYX (doxorubicin) Treatment Sequence BA | DRUG | Cycle 1 = Treatment B, Cycle 2 = Treatment A |
Inclusion Criteria: * Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group \[IMWG\] criteria * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Adequate absolute neutrophil count (ANC), platelet count and hemoglobin * Adequate serum calcium ...
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DOXIL/CAELYX is a doxorubicin product studied in breast cancer, multiple myeloma, and advanced or refractory solid malignancies including ovarian cancer. It has been evaluated both as a single agent and in combination regimens, such as with docetaxel in advanced breast cancer and with thalidomide plus dexamethasone in newly diagnosed multiple myeloma.
DOXIL/CAELYX is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical studies of the product in advanced solid malignancies, breast cancer, and multiple myeloma.
DOXIL/CAELYX has been studied in Phase 3 clinical development, including a Phase 3 trial in advanced breast cancer and a Phase 3 trial in newly diagnosed multiple myeloma. Earlier bioequivalence and Phase 1 studies in advanced or refractory solid malignancies have also been completed.
Completed studies include NCT00091442, a Phase 3 trial of docetaxel monotherapy versus DOXIL plus docetaxel in advanced breast cancer with 751 patients, and NCT00097981, a Phase 3 trial in newly diagnosed multiple myeloma with 225 patients. NCT01815294 and NCT02081495 were completed Phase 1 studies in advanced or refractory solid malignancies.