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
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
NCT01990352 Phase II Pegylated liposomal doxorubicin Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy Terminated USA 0
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
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
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
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
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
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
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
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
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
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
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
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
NCT06312176 Phase III Paclitaxel Capecitabine Pegylated liposomal doxorubicin Nab-paclitaxel Sacituzumab govitecan-hziy Pembrolizumab + Sacituzumab govitecan-hziy A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) Recruiting USA 2
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
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
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


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