Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi
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 12 Trials 
8 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Zamagni, Claudio
NCT02584478 / 2021-003871-32: Phase 1/2a/3 Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002)

Active, not recruiting
3
294
Europe, US, RoW
AL3818, Anlotinib Hydrochloride, Anlotinib, Catequentinib, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan, Daily Topotecan, Weekly Topotecan, Carboplatin, Paraplatin, Taxol
Advenchen Laboratories, LLC, Advenchen Laboratories, LLC
Endometrial Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Cervical Carcinoma
10/24
12/24
ENGOT-EN20, NCT05611931 / 2022-002540-42: Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Jul 2024 - Dec 2024: Top-line data from XPORT-EC trial in participants with TP53 wild type endometrial cancer
Recruiting
3
220
Europe, Canada, US, RoW
Selinexor, KPT-330, Matching Placebo for selinexor
Karyopharm Therapeutics Inc, GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgium and Luxembourg Gynaecological Oncology Group, North Eastern German Society of Gynaecological Oncology, Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies, Spanish Research Group in Ovarian Cancer, The Central and Eastern European Gynecologic Oncology Group, Israeli Society of Gynecologic Oncology, Australia New Zealand Gynaecological Oncology Group
Endometrial Cancer
01/25
01/28
ZEST, NCT04915755 / 2020-003973-23: Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

Calendar Jan 2025 - Dec 2025: Pivotal data from ZEST trial for HER2-negative BRCA-mutated or triple-negative breast cancer
Active, not recruiting
3
43
Europe, Canada, Japan, US, RoW
Niraparib, Placebo
GlaxoSmithKline
Neoplasms, Breast
06/24
12/25
EMBER-4, NCT05514054: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Recruiting
3
8000
Europe, Canada, Japan, US, RoW
Imlunestrant, LY3484356, Tamoxifen, Anastrozole, Letrozole, Exemestane
Eli Lilly and Company
Breast Neoplasms
10/27
03/32
PICCOLO, NCT05041257: Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers

Hourglass Oct 2024 - Dec 2024 : Approval for 2L+ FRα +ve PROC
Hourglass Jan 2024 - Jun 2024 : FDA action date for approval for ovarian cancer with high FRAC
Hourglass Jan 2024 - Jun 2024 : sBLA approval for ovarian cancer
Hourglass Jan 2023 - Dec 2023 : ORR data from PICCOLO trial for platinum sensitive ovarian cancer
Completed
2
79
Europe, Canada, US, RoW
Mirvetuximab soravtansine, MIRV, IMGN853
AbbVie
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
01/24
12/24
NCT06433219: Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Recruiting
2
60
Europe, US, RoW
Tuvusertib (M1774), M1774, VXc-400, VRT-1363004, substance code MSC2584415A, Niraparib, GSK3985771, MK-4827, Lartesertib (M4076), M4076, substance code MSC2585823A
EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany
Ovarian Cancer
01/28
01/28
PHERGAIN-2, NCT04733118 / 2020-003205-66: Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer

Active, not recruiting
2
393
Europe
Trastuzumab and Pertuzumab (FDC SC) and T-DM1, Trastuzumab emtansine, Phesgo, Kadcyla
MedSIR, Hoffmann-La Roche
Early Breast Cancer
09/25
03/28
Gelsomino, Francesco
CHANCE, NCT03976518: Atezolizumab in Advanced Non-small Cell Lung Cancer With Rare Histologies ( Trial)

Completed
2
43
Europe
Atezolizumab
Gruppo Oncologico Italiano di Ricerca Clinica, AOU S.Orsola Malpighi-Unit of Oncologic Molecular and Transplantations Pathology, Istituto Toscano Tumori, YGHEA, CRO Division of Ecol Studio spa, Iqvia Pty Ltd, AOU S. Orsola Malpighi - Clinical Trial Office, Silvano Chiapparoli Logistica SpA, Roche SpA
Non-Small Cell Lung Cancer
02/24
02/24
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Zamagni, Claudio
NCT02584478 / 2021-003871-32: Phase 1/2a/3 Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002)

Active, not recruiting
3
294
Europe, US, RoW
AL3818, Anlotinib Hydrochloride, Anlotinib, Catequentinib, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan, Daily Topotecan, Weekly Topotecan, Carboplatin, Paraplatin, Taxol
Advenchen Laboratories, LLC, Advenchen Laboratories, LLC
Endometrial Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Cervical Carcinoma
10/24
12/24
ENGOT-EN20, NCT05611931 / 2022-002540-42: Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Jul 2024 - Dec 2024: Top-line data from XPORT-EC trial in participants with TP53 wild type endometrial cancer
Recruiting
3
220
Europe, Canada, US, RoW
Selinexor, KPT-330, Matching Placebo for selinexor
Karyopharm Therapeutics Inc, GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgium and Luxembourg Gynaecological Oncology Group, North Eastern German Society of Gynaecological Oncology, Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies, Spanish Research Group in Ovarian Cancer, The Central and Eastern European Gynecologic Oncology Group, Israeli Society of Gynecologic Oncology, Australia New Zealand Gynaecological Oncology Group
Endometrial Cancer
01/25
01/28
ZEST, NCT04915755 / 2020-003973-23: Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

Calendar Jan 2025 - Dec 2025: Pivotal data from ZEST trial for HER2-negative BRCA-mutated or triple-negative breast cancer
Active, not recruiting
3
43
Europe, Canada, Japan, US, RoW
Niraparib, Placebo
GlaxoSmithKline
Neoplasms, Breast
06/24
12/25
EMBER-4, NCT05514054: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Recruiting
3
8000
Europe, Canada, Japan, US, RoW
Imlunestrant, LY3484356, Tamoxifen, Anastrozole, Letrozole, Exemestane
Eli Lilly and Company
Breast Neoplasms
10/27
03/32
PICCOLO, NCT05041257: Mirvetuximab Soravtansine Monotherapy in Platinum-Sensitive Epithelial, Peritoneal, and Fallopian Tube Cancers

Hourglass Oct 2024 - Dec 2024 : Approval for 2L+ FRα +ve PROC
Hourglass Jan 2024 - Jun 2024 : FDA action date for approval for ovarian cancer with high FRAC
Hourglass Jan 2024 - Jun 2024 : sBLA approval for ovarian cancer
Hourglass Jan 2023 - Dec 2023 : ORR data from PICCOLO trial for platinum sensitive ovarian cancer
Completed
2
79
Europe, Canada, US, RoW
Mirvetuximab soravtansine, MIRV, IMGN853
AbbVie
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
01/24
12/24
NCT06433219: Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

Recruiting
2
60
Europe, US, RoW
Tuvusertib (M1774), M1774, VXc-400, VRT-1363004, substance code MSC2584415A, Niraparib, GSK3985771, MK-4827, Lartesertib (M4076), M4076, substance code MSC2585823A
EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany
Ovarian Cancer
01/28
01/28
PHERGAIN-2, NCT04733118 / 2020-003205-66: Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer

Active, not recruiting
2
393
Europe
Trastuzumab and Pertuzumab (FDC SC) and T-DM1, Trastuzumab emtansine, Phesgo, Kadcyla
MedSIR, Hoffmann-La Roche
Early Breast Cancer
09/25
03/28
Gelsomino, Francesco
CHANCE, NCT03976518: Atezolizumab in Advanced Non-small Cell Lung Cancer With Rare Histologies ( Trial)

Completed
2
43
Europe
Atezolizumab
Gruppo Oncologico Italiano di Ricerca Clinica, AOU S.Orsola Malpighi-Unit of Oncologic Molecular and Transplantations Pathology, Istituto Toscano Tumori, YGHEA, CRO Division of Ecol Studio spa, Iqvia Pty Ltd, AOU S. Orsola Malpighi - Clinical Trial Office, Silvano Chiapparoli Logistica SpA, Roche SpA
Non-Small Cell Lung Cancer
02/24
02/24

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