University Hospital for Tumours of Zagreb Trials: Difference between revisions

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NCTID: NCT02562443

Title: Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA 
Study Summary: The study’s primary objective <math display="block">in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)</math>, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. 
Sponsor: Onconova Therapeutics, Inc. 
Intervention: rigosertib 
Start Date: 2015-12-02 
Last Updated: 2022-09-26 
Number of Patients: 372 
Recruitment Status: TERMINATED 
Condition: Myelodysplastic Syndrome

NCTID: NCT04736706

Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) 
Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).  The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-14 
Last Updated: 2023-12-04 
Number of Patients: 1653 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Renal Cell

NCTID: NCT01339260

Title: An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting 
Study Summary: NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy. 
Sponsor: Helsinn Healthcare SA 
Intervention: Netupitant and Palonosetron 
Start Date: 2011-04 
Last Updated: 2014-11-26 
Number of Patients: 1455 
Recruitment Status: COMPLETED 
Condition: Chemotherapy-Induced Nausea and Vomiting

NCTID: NCT00989131

Title: Study of Paclitaxel in Patients With Ovarian Cancer 
Study Summary: RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.  PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®. 
Sponsor: Oasmia Pharmaceutical AB 
Intervention: Paclical® 
Start Date: 2009-02 
Last Updated: 2014-02-04 
Number of Patients: 789 
Recruitment Status: COMPLETED 
Condition: Epithelial Ovarian Cancer

NCTID: NCT02668653

Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) 
Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.  Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).  Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: Chemotherapy 
Start Date: 2016-09-01 
Last Updated: 2023-11-18 
Number of Patients: 539 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia

NCTID: NCT04700124

Title: Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) 
Study Summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-21 
Last Updated: 2023-11-18 
Number of Patients: 784 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Muscle Invasive Bladder Cancer

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-’‘’NCTID’’‘: NCT00117572
+<span style="display:none">forresearchers</span>
+<span style="display:none">forpatients</span>
+<span style="display:none">forproviders</span>
+<span style="display:none">croatiacountry</span>
+<span style="display:none">hospital</span>
+<span style="display:none">cancer center</span>
+Go back to [[University Hospital for Tumours of Zagreb]] page
-’‘’Title’’‘: Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
+'''NCTID''': NCT02562443
+ '''Title''': [[hasTrialTitle::Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA]]
+ '''Study Summary''': The study’s primary objective <math display="block">in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)</math>, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.
+ '''Sponsor''': Onconova Therapeutics, Inc.
+ '''Intervention''': rigosertib
+ '''Start Date''': 2015-12-02
+ '''Last Updated''': 2022-09-26
+ '''Number of Patients''': 372
+ '''Recruitment Status''': TERMINATED
+ '''Condition''': Myelodysplastic Syndrome
-’‘’Study Summary’’‘: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.
+'''NCTID''': NCT04736706
+ '''Title''': [[hasTrialTitle::A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)]]
+ '''Study Summary''': The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).  The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
+ '''Sponsor''': Merck Sharp &amp; Dohme LLC
+ '''Intervention''': Pembrolizumab
+ '''Start Date''': 2021-04-14
+ '''Last Updated''': 2023-12-04
+ '''Number of Patients''': 1653
+ '''Recruitment Status''': RECRUITING
+ '''Condition''': Carcinoma, Renal Cell
-’‘’Sponsor’’‘: University of Chicago
+'''NCTID''': NCT01339260
+ '''Title''': [[hasTrialTitle::An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting]]
+ '''Study Summary''': NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.
+ '''Sponsor''': Helsinn Healthcare SA
+ '''Intervention''': Netupitant and Palonosetron
+ '''Start Date''': 2011-04
+ '''Last Updated''': 2014-11-26
+ '''Number of Patients''': 1455
+ '''Recruitment Status''': COMPLETED
+ '''Condition''': Chemotherapy-Induced Nausea and Vomiting
-’‘’Intervention’’‘: docetaxel
+'''NCTID''': NCT00989131
+ '''Title''': [[hasTrialTitle::Study of Paclitaxel in Patients With Ovarian Cancer]]
+ '''Study Summary''': RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.  PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.
+ '''Sponsor''': Oasmia Pharmaceutical AB
+ '''Intervention''': Paclical®
+ '''Start Date''': 2009-02
+ '''Last Updated''': 2014-02-04
+ '''Number of Patients''': 789
+ '''Recruitment Status''': COMPLETED
+ '''Condition''': Epithelial Ovarian Cancer
-’‘’Start Date’’‘: 2004-11
+'''NCTID''': NCT02668653
+ '''Title''': [[hasTrialTitle::Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)]]
+ '''Study Summary''': Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.  Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).  Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.
+ '''Sponsor''': Daiichi Sankyo, Inc.
+ '''Intervention''': Chemotherapy
+ '''Start Date''': 2016-09-01
+ '''Last Updated''': 2023-11-18
+ '''Number of Patients''': 539
+ '''Recruitment Status''': COMPLETED
+ '''Condition''': Acute Myeloid Leukemia
-’‘’Last Updated’’‘: 2018-04-09
+'''NCTID''': NCT04700124
+ '''Title''': [[hasTrialTitle::Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)]]
-’‘’Number of Patients’’‘: 285
+ '''Study Summary''': The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy <math display="block">gemcitabine plus cisplatin</math> and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
+ '''Sponsor''': Merck Sharp &amp; Dohme LLC
-’‘’Recruitment Status’’‘: COMPLETED
+ '''Intervention''': Pembrolizumab
+ '''Start Date''': 2021-04-21
-’‘’Condition’’‘: Cancer of the Pharynx
+ '''Last Updated''': 2023-11-18
+ '''Number of Patients''': 784
-’‘’NCTID’’‘: NCT00083304
+ '''Recruitment Status''': ACTIVE_NOT_RECRUITING
+ '''Condition''': Muscle Invasive Bladder Cancer
-’‘’Title’’‘: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
+<span style="display:none">hasTrialTitle::Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA</span>
+<span style="display:none">hasTrialTitle::A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)</span>
-’‘’Study Summary’’’: RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.
+<span style="display:none">hasTrialTitle::An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting</span>
+<span style="display:none">hasTrialTitle::Study of Paclitaxel in Patients With Ovarian Cancer</span>
-RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.
+<span style="display:none">hasTrialTitle::Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)</span>
+<span style="display:none">hasTrialTitle::Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)</span>
-This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.
-’‘’Sponsor’’‘: Spectrum Pharmaceuticals, Inc
-’‘’Intervention’’‘: Efaproxiral
-’‘’Start Date’’‘: 2004-02
-’‘’Last Updated’’‘: 2013-05-10
-’‘’Number of Patients’’‘: 368
-’‘’Recruitment Status’’‘: COMPLETED
-’‘’Condition’’‘: Breast Cancer
-’‘’NCTID’’‘: NCT00388726
-’‘’Title’’‘: E7389 Versus Treatment of Physician’s Choice in Patients With Locally Recurrent or Metastatic Breast Cancer
-’‘’Study Summary’’‘: The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician’s Choice (TPC) in patients with locally recurrent or metastatic breast cancer.
-’‘’Sponsor’’‘: Eisai Inc.
-’‘’Intervention’’‘: E7389
-’‘’Start Date’’‘: 2006-11
-’‘’Last Updated’’‘: 2020-01-07
-’‘’Number of Patients’’‘: 762
-’‘’Recruitment Status’’‘: COMPLETED
-’‘’Condition’’‘: Breast Cancer
-’‘’NCTID’’‘: NCT00479752
-’‘’Title’’‘: Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer
-’‘’Study Summary’’‘: To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.
-’‘’Sponsor’’‘: Central European Cooperative Oncology Group
-’‘’Intervention’’‘: FOLFOX4 (Oxaliplatin), Cetuximab
-’‘’Start Date’’‘: 2008-01
-’‘’Last Updated’’‘: 2016-02-18
-’‘’Number of Patients’’‘: 151
-’‘’Recruitment Status’’‘: COMPLETED
-’‘’Condition’’’: Colorectal Cancer