From 2010-2016 following Clinical
Studies have been conducted at the Oncology Institue of Vojvodina:
Principal investigator: prof. dr Dušan Jovanović
1. An
extension treatment protocol for subjects who have participated
in a Phase III study of Tivozanib hydrochloride vs Sorafenib in
renal cell carcinoma (AV-951-09-301).
Protocol No. AV-951-09-902
2. A
randomized, open-label, multicenter Phase IIIb study comparing
two trastuzumab dosing regimens, each in combination with cisplatin/capecitabine
chemotherapy, as first-line therapy in patients with H ER2-positive
metastatic gastric or gastro-esophageal junction adenocarcinoma
who have not received prior treatment for metastatic disease.
Protocol No. BO27798
3. A
double blinded randomised three armed phase II trial of PledOx®
in two different doses in combination with FOLFOX6 compared to
placebo + FOLFOX6 in patients with advanced metastatic colorectal
(stage IV) cancer.
Protocol No. PP095 (PLIANT)
4. A
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of
the Efficacy and Safety of CF102 in the Second-Line Treatment
of Advanced Hepatocellular Carcinoma in Subjects with Child-Pugh
Class B Cirrhosis
Protocol No. CF102-201HCC
5.
A multi-centre randomised clinical trial of biomarker-driven maintenance
treatment for first-line metastatic colorectal cancer.
Protocol No. MO29112
Principal investigator: prof. dr Jasna Trifunović
6. A
phase III trial of vinflunine + capecitabine versus capecitabine
alone in patients with advanced breast cancer previously treated
with or resistant to an anthracycline and who are taxane resistant.
Protocol No. L00070 IN 305 BO
7. An
international multi-centre open-label 2-arm phase III trial of
adjuvant bevacizumab in triple negative breast cancer.
Protocol No. BO20289
8. A
multicenter, double-blind, randomized, parallel-group, phase III
study of the efficacy and safety of Hercules plus Taxane versus
Herceptin plus Taxane as first line therapy in patients with HER2-positive
metastatic breast cancer.
Protocol No. MYL-Her-3001
9. A
multicenter, open-label, single-arm study of pertuzumab in combination
with trastuzumab and a taxane in first line positive advanced
(metastatic or locally recurrent) breast cancer.
Protocol No. MO28047
10.
FA Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy
and Safety of ABP 980 Compared with Trastuzumab in Subjects with
HER2 Positive Early Breast Cancer.
Protocol No. 20120283
11.
A randomized, multi-centre, assessor-blinded, active-controlled,
parallel-group, equivalence phase III study comparing the safety
and efficacy of usv pegfilgrastim and Neulasta in breast cancer
patients undergoing myelosuppressive chemotherapy.
Protocol No. PEGF/USV/P3/003
Principal investigator: prof. dr Darjana Jovanović
12.
A Phase III trial to compare the safety and efficacy of lapatinib
plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab
plus an AI versus lapatinib plus an AI as first- or second-line
therapy in postmenopausal subjects with hormone receptor positive,
HER2-positive metastatic breast cancer (MBC) who have received
prior trastuzumab and endocrine therapies.
Protocol No. EGF114299
13.
Phase III, Randomized, Double-Blind, Placebo-Controlled Study
of Vemurafenib (RO5185426) Adjuvant Therapy in Patients with Surgically-Resected
Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence.
Protocol No. GO27826
14.
Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment
Versus Anticoagulation with a Vitamin K Antagonist (Warfarin)
for the Treatment of Acute Venous Thromboembolism in Cancer Patients.
Protocol No. IN 0901 INT
15.
Randomized Phase 4 Study Comparing 2 Intravenous Temsirolimus
(TEMSR) Regimens in Subjects With Relapsed, Refractory Mantle
Cell Lymphoma.
Protocol No. 3066K1-4438-WW (Pfizer Protocol B1771007)
16.
A double-blind, placebo-controlled, randomized, phase III b trial
evaluating the efficacy and safety of standard of care (SOC) +/-
continuous bevacizumab treatment following progression of disease
(PD) in patients with glioblastoma (GBM) after first (1st)-line
treatment with radiotherapy, temozolomide and bevacizumab.
Protocol No. M028347
17.
A comparative, randomized, parallel-group, multicenter, phase
IIIb study to investigate efficacy of subcutaneous (SC) rituximab
versus intravenous (IV) rituximab both in combination with CHOP
(R-CHOP) in previously untreated patients with CD20 positive diffuse
large B-cell lymphoma (DLBCL).
Protocol No. M02810
18.
A phase 3, randomized, double-blind study of PF-05280014 plus
paclitaxel versus trastuzumab plus paclitaxel for the first line
treatment of patients with HER2 positive metastatic breast cancer
.
Protocol No. B3271002
19.
A Randomized, Double-Blind Pharmacokinetic Study of PF-05280014
Plus Taxotere® and Carboplatin Versus Herceptin® Plus Taxotere®
and Carboplatin for the Neoadjuvant Treatment of Patients with
Operable HER2-Positive Breast Cancer.
Protocol No. B3271004
20.
A Phase 3, Randomized, Controlled, Open-label Study of VELCADE
(Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab
in Combination with VMP (D VMP), in Subjects with Previously Untreated
Multiple Myeloma who are Ineligible for High-dose Therapy.
Protocol No. 54767414MMY3007
21.
A Phase 2b Open-label, Randomized, Two-arm Study Comparing High
and Low Doses of Selinexor (KPT-330) in Patients with Relapsed/Refractory
Diffuse Large B-Cell Lymphoma (DLBCL).
Protocol No. KCP-330-009
22.
A phase III, double-blind, placebo-controlled, randomized study
of taselisib plus fulvestrant versus placebo plus fulvestrant
in postmenopausal women with estrogen receptor-positive and HER2
negative locally advanced or metastatic breast cancer who have
disease recurrence or progression during or after aromatase inhibitor
therapy.
Protocol No. GO29058
23.
Open-label, non-randomized phase 2 study with safety run-in evaluating
efficacy and safety of PQR309 in patients with relapsed or refractory
lymphoma.
Protocol No. PQR309-002
24.
A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous
Stem-CellTransplantation (ASCT)- B-MIND.
Protocol No. MOR208C204
Principal investigator: prim. dr Jasna Pešić
25.
A phase III prospective, two-cohort non-randomized, multi-centre,
multinational, open label study to assess the safety of assisted
and self-administered subcutaneous trastuzumab as therapy in patients
with operable HER2-positive early breast cancer.
Protocol No. MO28048
26.
A randomized, multicenter, open-label phase III study to evaluate
the efficacy and safety of trastuzumab emtansine versus trastuzumab
as adjuvant therapy for patients with HER2-positive primary breast
cancer who have residual tumor present pathologically in the breast
or axillary lymph nodes following preoperative therapy.
Protocol No. BO27938
Principal investigator: dr Eržebet Patarica-Huber
27.
Open-label, single-arm, flexible dosing, Phase III trial, with
oral tapentadol PR in subjects with chronic malignant tumor-related
pain who have completed the Maintenance Period of the KF5503/15
trial.
Protocol No. KF5503/52
28.
Efficacy, safety and tolerability of oral cebranopadol versus
morphine sulfate PR in subjects with chronic moderate to severe
pain related to cancer..
Protocol No. KF6005/07
29.
An open-label, multi-site trial to describe the safety and tolerability
of oral cebranopadol administered for 26 weeks in subjects with
cancer-related pain who have completed treatment in the KF6005/07
trial.
Protocol No. KF6005/09
30.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter
Study of the Analgesic Efficacy and Safety of the Subcutaneous
Administration of Tanezumab (PF-04383119) in Subjects with Cancer
Pain Predominantly Due to Bone Metastases Receiving Background
Opioid Therapy.
Protocol No. A4091061
31.
Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase III Trial to Investigate the Efficacy, Safety and Tolerability of Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation.
Protocol No. 0217/DEV
Principal investigator: prof. dr Marko Erak
32.
A Phase III, Open-label, Randomized, Multi-center Study of the
Effects of Leukocyte Interleukin, Injection [Multikine®] Plus
Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent
Chemoradiotherapy) in Subjects with Advanced Primary Squamous
Cell Carcinoma of the Oral Cavity and Soft Palate Versus Standard
of Care Only.
Protocol No. CSOO1P3
Principal investigator: asst prof. dr Lazar Popović
33.
A phase III, open-label, multicenter, randomized study to investigate
the efficacy and safety of MPDL3280A (anti-PD-L1 antibody) compared
with chemotherapy in patients with locally advanced or metastatic
urothelial bladder cancer after failure with platinum-containing
chemotherapy.
Protocol No. GO29294
34.
A phase 3, multicenter, randomized, double-blind, active control
study to evaluate the safety and the efficacy of IV pro-netupitant
/ palonosetron (260 mg / 0.25 mg) combination for the prevention
of chemotherapy-induced nausea and vomiting in repeated chemotherapy
cycles in patients receiving highly emetogenic chemotherapy.
Protocol No. NEPA-15-18
35.
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma.
Protocol No. AGB 002
36.
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAS-102 in Patients With Advanced Solid Tumors and Varying Degrees of Renal Impairment.
Protocol No. TO-TAS-102-107
37.
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti−PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma.
Protocol No. WO30070
38.
A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy.
Protocol No. B-701-U22
39.
Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients with Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy.
Protocol No. G1T28-04
40.
A Phase 3, Multicenter, Multinational, Randomized, Open-label, Parallel-arm
Study Of Avelumab (MSB0010718C) Plus Best Supportive Care Versus Best
Supportive Care Alone As A Maintenance Treatment In Patients With Locally
Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress
After Completion Of First-line Platinum-containing Chemotherapy.
Protocol No. B9991001
Principal investigator: asst prof. dr Jelka Rajović
41.
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)
versus Pegylated Liposomal Doxorubicin or Topotecan in Patients
with Platinum-resistant Ovarian Cancer.
Protocol No. CORAIL
Principal investigator: prim. dr Borislava Nikolin
42.
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy.
Protocol No. D4193C00002
43.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to
Determine the Safety and Efficacy of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients With High-Risk Squamous Cell Carcinoma of the Oral Cavity.
Protocol No. GL0817-01
Principal investigator: dr Biljana Kukić
44.
A multi-centre randomised clinical trial of biomarker-driven maintenance treatment for first-line metastatic colorectal cancer.
Protocol No. MO29112
Principal investigator: dr Svetlana Salma
35.
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy.
Protocol No. WO39210
Principal investigator: dr Gorana Matovina Brko
45.
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer.
Protocol No. WO39193
Principal investigator: dr Aljoša Mandić
46.
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum-resistant Ovarian Cancer.
Protocol No. PM1183-C-004-14
Principal investigator: prim. dr Katarina Mastilović, PhD
47.
Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV.
Protocol No. ADXS001-02
Principal investigator: dr Igor Đan
48.
A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine®] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity and Soft Palate Versus Standard of Care Only.
Protocol No. CSOO1P3
Laboratory research:
Biologic
activities of derivative fullerene C60 - in vitro and in vivo
models
MRI
and UV-VIS spectroscopy malignant body fluids
Scrining
of anti-tumor drugs (cis-platinum derivatives, daunorubicin derivatives,
tiazofurin derivatives)
Primary
human cell culture - characterization and identification
Genetic
abnormalities in patients with limphomas
MDR
studies of primary human carcinomas