Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DOXIL/CAELYX Treatment Sequence AB · 2 trials · 4 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Having advanced or refractory solid malignancies (histologically or cytologically confirmed advanced ovarian cancer failing platinum-based chemotherapy or metastatic breast cancer after failing approved life prolonging therapies or any solid malignancy that is metastatic or un...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
DOXIL is used for the treatment of multiple myeloma, breast cancer, and other neoplasms. It is being studied in patients with advanced or refractory solid malignancies, including ovarian cancer. The drug is currently in Phase 3 clinical trials for these indications.
DOXIL is a small molecule that targets cancer cells. It is a formulation of doxorubicin, an anthracycline antibiotic that works by intercalating DNA and inhibiting topoisomerase II, leading to cell death. This mechanism is effective against rapidly dividing cancer cells.
DOXIL is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's efficacy in various oncology indications.
DOXIL is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trials are completed, and the drug is being studied for multiple myeloma and breast cancer.
DOXIL has been studied in several clinical trials, including NCT00091442, a Phase 3 study of docetaxel with or without DOXIL in advanced breast cancer, and NCT00097981, a Phase 3 study of thalidomide plus dexamethasone with or without DOXIL in newly diagnosed multiple myeloma. Both trials are completed.
Yes, DOXIL is also known as CAELYX. Clinical trials such as NCT01815294 and NCT02081495 refer to the drug as DOXIL/CAELYX, indicating that these names are used interchangeably for the same formulation of doxorubicin.