Therapy Detail
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| Therapy Name | Pegylated liposomal doxorubicin |
| Synonyms | |
| Therapy Description |
Doxil (pegylated liposomal doxorubicin) comprises the anthracyline doxorubicin, which intercalates into DNA and disrupts DNA replication, encapsulated in a liposome, which improves tumor penetration and decreases toxicity (NCI Drug Dictionary), and is FDA approved for ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Pegylated liposomal doxorubicin | Doxil | ATI-0918|CAELYX|liposomal doxorubicin | Chemotherapy - Anthracycline 13 | Doxil (pegylated liposomal doxorubicin) comprises the anthracyline doxorubicin, which intercalates into DNA and disrupts DNA replication, encapsulated in a liposome, which improves tumor penetration and decreases toxicity (NCI Drug Dictionary), and is FDA approved for ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02081495 | Phase I | Pegylated liposomal doxorubicin | A Study of DOXIL/CAELYX in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer | Completed | USA | ESP | CAN | BEL | 0 |
| NCT05092360 | Phase III | Pembrolizumab ALKS 4230 Topotecan Paclitaxel Pegylated liposomal doxorubicin Gemcitabine ALKS 4230 + Pembrolizumab | Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab (ARTISTRY-7) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 5 |
| NCT06072781 | Phase III | Paclitaxel Pegylated liposomal doxorubicin Defactinib + RO5126766 Topotecan Anastrozole Letrozole | A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer (RAMP 301) | Recruiting | USA | AUS | 0 |
| NCT01846611 | Phase III | Pegylated liposomal doxorubicin Dexamethasone | A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Completed | USA | NZL | GBR | AUS | 6 |
| NCT04895358 | Phase III | Nab-paclitaxel Nab-paclitaxel + Pembrolizumab Capecitabine + Pembrolizumab Paclitaxel + Pembrolizumab Capecitabine Pegylated liposomal doxorubicin Paclitaxel Pegylated liposomal doxorubicin + Pembrolizumab | Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 21 |
| NCT00092222 | Phase II | Sirolimus Alpha 2 Interferon Cyclophosphamide + Doxorubicin + Etoposide + Prednisone + Vincristine Sulfate Rituximab Bortezomib Pegylated liposomal doxorubicin | Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity | Active, not recruiting | USA | 0 |
| NCT01991210 | Phase II | DNIB0600A Pegylated liposomal doxorubicin | A Randomized Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer | Terminated | USA | GBR | FRA | ESP | CAN | BEL | 1 |
| NCT01990352 | Phase II | Pegylated liposomal doxorubicin | Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy | Terminated | USA | 0 |
| NCT02282020 | Phase III | Topotecan Paclitaxel Pegylated liposomal doxorubicin Gemcitabine Olaparib | Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments (SOLO3) | Completed | USA | ITA | ESP | CAN | BEL | 8 |
| NCT05295589 | Phase II | Topotecan Pegylated liposomal doxorubicin Copanlisib + Olaparib Paclitaxel | Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy | Withdrawn | USA | 0 |
| NCT02456857 | Phase II | Bevacizumab Everolimus Pegylated liposomal doxorubicin | Liposomal Doxorubicin, Bevacizumab, and Everolimus in Patients With Locally Advanced TNBC With Tumors Predicted Insensitive to Standard Chemotherapy; A Moonshot Initiative | Completed | USA | 0 |
| NCT03639246 | Phase Ib/II | AVB-S6-500 + Paclitaxel AVB-S6-500 + Pegylated liposomal doxorubicin Paclitaxel Pegylated liposomal doxorubicin | Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer | Completed | USA | 0 |
| NCT04679064 | Phase III | Bevacizumab + Gemcitabine Dostarlimab-gxly + Niraparib Pegylated liposomal doxorubicin Bevacizumab + Topotecan Paclitaxel Topotecan Bevacizumab + Paclitaxel Bevacizumab + Pegylated liposomal doxorubicin Gemcitabine | Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment (NItCHE-MITO33) | Recruiting | ITA | 0 |
| NCT04729387 | Phase III | Pegylated liposomal doxorubicin Paclitaxel Alpelisib + Olaparib | Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 15 |
| NCT02364713 | Phase II | Pegylated liposomal doxorubicin Bevacizumab + Topotecan Topotecan Paclitaxel MV-NIS Bevacizumab + Paclitaxel Bevacizumab + Pegylated liposomal doxorubicin Gemcitabine | MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer | Active, not recruiting | USA | 0 |
| NCT04209855 | Phase III | Paclitaxel Pegylated liposomal doxorubicin Mirvetuximab Soravtansine Topotecan | A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 11 |
| NCT01815294 | Phase I | Doxorubicin Pegylated liposomal doxorubicin | A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer | Completed | USA | GBR | ESP | BEL | 0 |
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