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DRUG:
Zepzelca (lurbinectedin)
i
Other names:
PM1183, PM01183, PM 1183, PM-01183, LY01017, PM-1183, LY 01017, LY-01017, PM 01183
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Associations
(11)
News
Trials
Company:
Boryung Group, Jazz, Key Oncologics, Luye Group, Merck (MSD), PharmaMar, Specialised Therap
Drug class:
Alkylating agent, Apoptosis stimulant, RNA polymerase inhibitor
Related drugs:
‹
cyclophosphamide (66)
trabectedin (24)
STAR-001 (16)
lomustine (15)
carmustine (14)
melphalan (9)
chlorambucil (7)
melphalan flufenamide (7)
temozolomide gel (7)
procarbazine hydrochloride (4)
OBI-3424 (4)
D19466 (4)
mitomycin (3)
thiotepa (3)
bendamustine RTD (2)
LP-284 (2)
fotemustine (2)
busulfan (2)
VAL-083 (2)
ACHM-025 (1)
BYON4413 (1)
FGX15-147-based ADC (1)
treosulfan (1)
IMGS-101 (1)
bendamustine rapid infusion (0)
ranimustine (0)
carmustine implant (0)
TL-118 (0)
altretamine (0)
mechlorethamine (0)
satraplatin (0)
PR104 (0)
pegylated liposomal mitomycin-c prodrug (0)
QBS72S (0)
mechlorethamine gel (0)
EX-204 (0)
captisol-enabled melphalan (0)
cyclophosphamide intravenous (0)
D 19575 (0)
CB1954 (0)
arsenic trioxide (6)
STA-4783 (5)
pelareorep (4)
omacetaxine mepesuccinate (4)
GZ17-6.02 (3)
quaratusugene ozeplasmid (3)
BAL101553 (3)
teserpaturev (1)
IT-141 (1)
Alpha1H (1)
NEO100 (1)
ABI-1968 topical cream (0)
APTO-253 (0)
BP-C1 (0)
BXQ-350 (0)
CM-728 (0)
IL-17E (0)
autologous γδ T lymphocytes (0)
KLTi (0)
MT-3724 (0)
84AA-API 14AA (0)
PVT-1 (0)
SVV-001 (0)
alpha-tocopheroloxyacetic acid (0)
darinaparsin (0)
AFP-464 (0)
elemene injection (0)
BAY1862864 (0)
BS-HH-002.SA (0)
PT-112 (0)
K-333 (0)
piceatannol (0)
AP1903 (0)
PRX302 (0)
silibinin (0)
ranpirnase (0)
TAS-106 (0)
rifampicin (0)
cyclophosphamide (66)
trabectedin (24)
STAR-001 (16)
lomustine (15)
carmustine (14)
melphalan (9)
chlorambucil (7)
melphalan flufenamide (7)
temozolomide gel (7)
procarbazine hydrochloride (4)
OBI-3424 (4)
D19466 (4)
mitomycin (3)
thiotepa (3)
bendamustine RTD (2)
LP-284 (2)
fotemustine (2)
busulfan (2)
VAL-083 (2)
ACHM-025 (1)
BYON4413 (1)
FGX15-147-based ADC (1)
treosulfan (1)
IMGS-101 (1)
bendamustine rapid infusion (0)
ranimustine (0)
carmustine implant (0)
TL-118 (0)
altretamine (0)
mechlorethamine (0)
satraplatin (0)
PR104 (0)
pegylated liposomal mitomycin-c prodrug (0)
QBS72S (0)
mechlorethamine gel (0)
EX-204 (0)
captisol-enabled melphalan (0)
cyclophosphamide intravenous (0)
D 19575 (0)
CB1954 (0)
arsenic trioxide (6)
STA-4783 (5)
pelareorep (4)
omacetaxine mepesuccinate (4)
GZ17-6.02 (3)
quaratusugene ozeplasmid (3)
BAL101553 (3)
teserpaturev (1)
IT-141 (1)
Alpha1H (1)
NEO100 (1)
ABI-1968 topical cream (0)
APTO-253 (0)
BP-C1 (0)
BXQ-350 (0)
CM-728 (0)
IL-17E (0)
autologous γδ T lymphocytes (0)
KLTi (0)
MT-3724 (0)
84AA-API 14AA (0)
PVT-1 (0)
SVV-001 (0)
alpha-tocopheroloxyacetic acid (0)
darinaparsin (0)
AFP-464 (0)
elemene injection (0)
BAY1862864 (0)
BS-HH-002.SA (0)
PT-112 (0)
K-333 (0)
piceatannol (0)
AP1903 (0)
PRX302 (0)
silibinin (0)
ranpirnase (0)
TAS-106 (0)
rifampicin (0)
›
Associations
(11)
News
Trials
Phase
Status
Apply
Phase
Status
Apply
Lurbinectedin in FET-Fused Tumors (LiFFT) (NCT05918640)
Phase 1/2
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Recruiting
Phase 1/2
Children's Hospital of Philadelphia
Recruiting
Last update posted :
02/13/2025
Initiation :
07/27/2023
Primary completion :
07/30/2026
Completion :
07/30/2028
EWSR1 • ETV1 • FLI1 • FUS • TAF15 • ETV4
|
Zepzelca (lurbinectedin)
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (NCI-MATCH) (NCT02465060)
Phase 2
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Active, not recruiting
Phase 2
National Cancer Institute (NCI)
Active, not recruiting
Last update posted :
02/06/2025
Initiation :
08/17/2015
Primary completion :
12/31/2025
Completion :
12/31/2025
MSI • CD4
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Mekinist (trametinib) • cisplatin • Xalkori (crizotinib) • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • dasatinib • Tafinlar (dabrafenib) • carboplatin • Imfinzi (durvalumab) • Vitrakvi (larotrectinib) • Imbruvica (ibrutinib) • gemcitabine • paclitaxel • Rituxan (rituximab) • docetaxel • 5-fluorouracil • sunitinib • everolimus • Vectibix (panitumumab) • temozolomide • Koselugo (selumetinib) • Perjeta (pertuzumab) • cytarabine • Kadcyla (ado-trastuzumab emtansine) • bortezomib • doxorubicin hydrochloride • Talzenna (talazoparib) • capecitabine • Piqray (alpelisib) • Xtandi (enzalutamide) • azacitidine • Cabometyx (cabozantinib tablet) • Balversa (erdafitinib) • Gazyva (obinutuzumab) • Mektovi (binimetinib) • albumin-bound paclitaxel • cyclophosphamide • Imjudo (tremelimumab-actl) • Cyramza (ramucirumab) • pemetrexed • fulvestrant • oxaliplatin • adavosertib (AZD1775) • etoposide IV • irinotecan • Halaven (eribulin mesylate) • Xpovio (selinexor) • Conmana (icotinib) • Pemazyre (pemigatinib) • Truqap (capivasertib) • methotrexate • Zarnestra (tipifarnib) • Aliqopa (copanlisib) • fexagratinib (ABSK091) • Ninlaro (ixazomib) • pegylated liposomal doxorubicin • epirubicin • sapanisertib (CB-228) • ipatasertib (RG7440) • Caprelsa (vandetanib) • vincristine • vinorelbine tartrate • Cometriq (cabozantinib capsule) • Tabrecta (capmatinib) • spartalizumab (PDR001) • taselisib (GDC-0032) • daunorubicin • omipalisib (GSK2126458) • ulixertinib (BVD-523) • mitoxantrone • Erivedge (vismodegib) • carmustine • bendamustine • bicalutamide • leucovorin calcium • Mvasi (bevacizumab-awwb) • Vegzelma (bevacizumab-adcd) • Zepzelca (lurbinectedin) • mitomycin • Jingzhuda (entinostat) • Recentin (cediranib) • Trazimera (trastuzumab-qyyp) • melphalan • GSK2636771 • Zirabev (bevacizumab-bvzr) • defactinib (VS-6063) • goserelin acetate • Zynyz (retifanlimab-dlwr) • fludarabine IV • Ostarine (enobosarm) • avadomide (CC-122) • vistusertib (AZD2014) • Myocet (non-pegylated liposomal doxorubicin) • mesna • vinblastine • Xofigo (radium Ra-223 dichloride) • lorvotuzumab mertansine (IMGN901) • Ampligen (rintatolimod) • E6201 • Fujovee (abivertinib) • Provenge (sipuleucel-T) • TQB2440 (pertuzumab biosimilar) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar) • Airuituo (bevacizumab biosimilar) • BCD-178 (pertuzumab biosimilar) • Beianting (bevacizumab biosimilar) • Boyounuo (bevacizumab biosimilar) • CC-90002 • EG1206A (pertuzumab biosimilar) • GB222 (bevacizumab biosimilar) • Hanbeitai (bevacizumab biosimilar) • ImmuniCell (autologous γδ T lymphocytes) • Leukine (sargramostim) • Vasforda (bevacizumab biosimilar) • celecoxib oral • cyclophosphamide intravenous • dexamethasone injection • ieramilimab (LAG525) • levoleucovorin calcium • methotrexate IV • sapitinib (AZD8931)
Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer (LURBIMUNE) (NCT05572476)
Phase 2
Institut Bergonié
Institut Bergonié
Withdrawn
Phase 2
Institut Bergonié
Withdrawn
Last update posted :
06/05/2024
Initiation :
10/01/2023
Primary completion :
05/31/2024
Completion :
05/31/2024
PD-L1
|
carboplatin • Imfinzi (durvalumab) • etoposide IV • Zepzelca (lurbinectedin)
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors (PM1183-A-014-15) (NCT02611024)
Phase 1/2
PharmaMar
PharmaMar
Recruiting
Phase 1/2
PharmaMar
Recruiting
Last update posted :
04/30/2024
Initiation :
05/06/2016
Primary completion :
03/01/2026
Completion :
03/01/2026
PD-L1
|
irinotecan • Zepzelca (lurbinectedin)
Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer (NCT05800587)
Phase 2
Fox Chase Cancer Center
Fox Chase Cancer Center
Recruiting
Phase 2
Fox Chase Cancer Center
Recruiting
Last update posted :
03/26/2024
Initiation :
02/22/2023
Primary completion :
08/01/2028
Completion :
08/01/2029
CD4
|
carboplatin • gemcitabine • docetaxel • albumin-bound paclitaxel • pemetrexed • etoposide IV • irinotecan • topotecan • Zepzelca (lurbinectedin)
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201) (NCT05126433)
Phase 2
Jazz Pharmaceuticals
Jazz Pharmaceuticals
Completed
Phase 2
Jazz Pharmaceuticals
Completed
Last update posted :
02/26/2024
Initiation :
03/03/2022
Primary completion :
12/20/2023
Completion :
12/20/2023
HER-2 • HRD
|
HER-2 negative
|
Zepzelca (lurbinectedin)
Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations (NCT05229588)
Phase 2
HonorHealth Research Institute
HonorHealth Research Institute
Recruiting
Phase 2
HonorHealth Research Institute
Recruiting
Last update posted :
02/02/2024
Initiation :
06/14/2022
Primary completion :
08/31/2025
Completion :
08/31/2026
BRCA1 • BRCA2 • PTEN • ARID1A • CHEK2 • RAD51 • BRIP1 • NBN • EMSY
|
BRCA1 mutation • ATM mutation • PTEN mutation • PALB2 mutation • CHEK2 mutation • BRIP1 mutation • NBN mutation • RAD51 mutation
|
Zepzelca (lurbinectedin)
Study of Trilaciclib and Lurbinectidin (NCT05578326)
Phase 2
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
Recruiting
Phase 2
UNC Lineberger Comprehensive Cancer Center
Recruiting
Last update posted :
11/16/2023
Initiation :
10/12/2022
Primary completion :
07/25/2024
Completion :
07/25/2026
PD-L1
|
Zepzelca (lurbinectedin) • Cosela (trilaciclib)
Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer (NCT04607954)
Phase 2
Mayo Clinic
Mayo Clinic
Recruiting
Phase 2
Mayo Clinic
Recruiting
Last update posted :
07/24/2023
Initiation :
12/04/2020
Primary completion :
11/01/2024
Completion :
11/01/2025
PD-L1
|
Imfinzi (durvalumab) • topotecan • Zepzelca (lurbinectedin)
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (NCT02454972)
Phase 2
PharmaMar
PharmaMar
Completed
Phase 2
PharmaMar
Completed
Last update posted :
03/02/2023
Initiation :
08/25/2015
Primary completion :
09/18/2020
Completion :
09/18/2020
BRCA1 • BRCA2 • BRCA
|
Zepzelca (lurbinectedin)
Lurbinectedin With or Without Irinotecan in Treating Patients With Relapsed or High Risk Metastatic Ewing Sarcoma (NCT05042934)
Phase 1b/2
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Withdrawn
Phase 1b/2
M.D. Anderson Cancer Center
Withdrawn
Last update posted :
02/10/2022
Initiation :
09/15/2021
Primary completion :
08/30/2022
Completion :
08/30/2022
EWSR1 • FLI1 • WRN • RECQL
|
irinotecan • Zepzelca (lurbinectedin)
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer (NCT01525589)
Phase 2
PharmaMar
PharmaMar
Completed
Phase 2
PharmaMar
Completed
Last update posted :
09/25/2020
Initiation :
06/13/2012
Primary completion :
10/01/2018
Completion :
10/01/2018
HER-2 • BRCA1 • BRCA2
|
BRCA2 mutation • BRCA1 mutation • HER-2 overexpression
|
Zepzelca (lurbinectedin)
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients (CORAIL) (NCT02421588)
Phase 3
PharmaMar
PharmaMar
Completed
Phase 3
PharmaMar
Completed
Last update posted :
04/03/2020
Initiation :
05/01/2015
Primary completion :
10/12/2018
Completion :
10/12/2018
MUC16
|
pegylated liposomal doxorubicin • topotecan • Zepzelca (lurbinectedin)
Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors (POLA) (NCT02684318)
Phase 1/2
Poveda, Andrés, M.D.
Poveda, Andrés, M.D.
Unknown status
Phase 1/2
Poveda, Andrés, M.D.
Unknown status
Last update posted :
06/22/2017
Initiation :
07/01/2015
Primary completion :
07/01/2019
Completion :
10/01/2019
BRCA1 • PTEN • PARP1
|
BRCA2 mutation • BRCA1 mutation • HRD + BRCA1 mutation
|
Lynparza (olaparib) • Zepzelca (lurbinectedin)
Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome (NCT01314599)
Phase 1
PharmaMar
PharmaMar
Completed
Phase 1
PharmaMar
Completed
Last update posted :
11/05/2015
Initiation :
05/01/2011
Primary completion :
07/01/2015
Completion :
07/01/2015
ABL1 • BCR
|
Zepzelca (lurbinectedin)
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