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Clinical trials group

What is the importance of clinical trials to our patient?

Clinical trials are the possibilities for our doctors to be involved in research of new possible medical agents and for our patients to take a few steps forward and get the most novel treatment before it becomes available.

Clinical trials is priority oncology area, which ensure the emergence of new effective medicines, biomarker research, and justification of medical methodologies by evidence and science. More than 20 phase II, phase III, and phase IV clinical trials, involving approximately 100 patients and 15% of institute staff, are performed in National Cancer Institute every year. Clinical trials of various localizations solid tumors are performed; but the most common are in the areas of breast, prostate, lung, stomach, pancreas and head-neck tumors. Phase I clinical trials will be started in the near future.

Working in the area of clinical trials for more than 15 years, we managed to create the clinical trials coordination structure involving the professional and skilled staff. This allows us to ensure high quality implementation of clinical trials, following the guidelines for good clinical practice. All implemented clinical trials are approved by the Lithuanian Bioethics Committee and the State Medicines Control Agency.

Currently, 24 clinical trials are performed in the Institute; 8 of them are actively recruiting patients.

We have the possibility to carry out trials of all phases, from I to IV, in the Institute.


List of clinical trials

 

 No.

 

Lokalization

 

Name of the study

 

Principal Investigator

 

The state of the study

Open for inclusion

1.

PROSTATE CANCER

LPC-004

„A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer, Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))“

Albertas Ulys

 

 

Inclusion of patients

2.

MELANOMA

CDRB436F2410

„Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus)“

Birutė Brasiūnienė

 

 

Inclusion of patients

3.

NON-SMALL CELL LUNG CANCER

R2810-ONC-16111

„A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%“

Saulius Cicėnas

 

 

 

 

Inclusion of patients

4.

NON-SMALL CELL LUNG CANCER

R2810-ONC-16113

„A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%“

Saulius Cicėnas

 

 

 

Inclusion of patients

5.

PROSTATE ADENOCARCINOMA

UROLUD-4

„A prospective observational study of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with metastatic castrate-resistant prostate cancer“

Albertas Ulys

Inclusion of patients

6.

GEP NET

Nr. A-99-52030-286

“Exploratory, non-interventional study for evaluating the diagnostic, prognostic and response-predictive value of a multi biomarker approach in metastatic GEP NETs”

Edita Baltruškevičienė

Inclusion of patients

 

7.

PANCREATIC CANCER

HALO-109-301

“A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab‑Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab‑Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma.”

 

Edita Baltruškevičienė

 

 

Inclusion of patients

8.

SMALL CELL LUNG CANCER

M16-298

„A Randomized, Double-Blind, Placebo-Controlled Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)“

Birutė Brasiūnienė

Inclusion of patients

 

Closed for inclusion

9.

GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA

MK-3475-062

„A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.“

Edita Baltruškevičienė

 

 

 

Active treatment

 

 

10.

URINARY TRACT CARCINOMA

MO29983

„An open label, single arm, multicenter, safety study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract“

Birutė Brasiūnienė

 

 

Active treatment

 

11.

NON-SMALL CELL LUNG CANCER

1199.223

„A non-interventional biomarker study in patients with Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology eligible for treatment with Vargatef® according to the approved label“

Saulius Cicėnas

 

 

Active treatment

 

 

12.

PROSTATE CANCER

FP01C-17-001

„An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects with Prostate Cancer“

Feliksas Jankevičius

 

Active treatment

 

13.

GASTRIC CANCER

ASLAN001-012

„A Two-Part Phase 2/3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Of Varlitinib Plus mFOLFOX6 Versus Placebo Plus mFOLFOX6 in Subjects with HER1/ HER2 Co-Expressing Advanced or Metastatic Gastric Cancer Without Prior Exposure to Systemic Therapy“

Edita Baltruškevičienė

 

 

 

Ongoing

 

 

 

14.

MELANOMA

CDRB436B2404

„Describe III: Retrospective chart review of dabrafenib monotherapy and/or dabrafenib-trametinib combination therapy in patients with metastatic melanoma to characterize patients with long term benefit in the Individual Patient Program (IPP)“

Edita Baltruškevičienė

Ongoing

15.

SMALL CELL LUNG CANCER

DIV-SCLC-301

„A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer“

Saulius Cicėnas

 

 

Active treatment

 

 

 

16.

BREAST CANCER

EGF106903

„A randomised, multicentre, open-label, phase III study of neoadjuvant lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer“

Audronė Cicėnienė

Observation of patients

17.

BREAST CANCER

3144A2-3004-WW

„A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer“

Audronė Cicėnienė

Observation of patients

18.

BREAST CANCER

MO28047

„A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer.“

Eduardas Aleknavičius

Active treatment

 

19.

NON-SMALL CELL LUNG CANCER

MK-3475-042

„A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) versus Platinum Based Chemotherapy in Treatment Naïve Subjects with PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042).“

Saulius Cicėnas

Observation of patients

20.

BREAST CANCER

M12-914

„A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer.“

Valerijus Ostapenko

 

 

Active treatment

 

21.

PROSTATE CANCER

SP005

„A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy.“

Jolita Asadauskienė

 

 

 

 

Active treatment

 

 

22.

PROSTATE CANCER

3104007

„A Multinational Randomised, Double- Blind, Placebo-Controlled, Phase III Efficacy And Safety Study Of ODM-201 In Men With High-Risk Non-Metastatic Castration-Resistant Prostate Cancer.“

Albertas Ulys

 

 

Active treatment

 

23.

NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

GO29436

„A phase 3, open-label, randomized study of mpdl3280a (anti-pd-l1 antibody) in combination with carboplatin - paclitaxel with or without bevacizumab compared with carboplatin -paclitaxel - bevacizumab in chemotherapy naïve patients with stage iv non-squamous non-small cell lung cancer.“

Saulius Cicėnas

 

 

 

Observation of patients

 

24.

NON-SMALL CELL LUNG CANCER

TREM

„AZD9291, an irreversible EGFR-TKI, in relapsed EGFR-mutated non-small cell lung cancer patients previously treated with an EGFR-TKI, coupled to extensive translational studies.“

Saulius Cicėnas

Active treatment

 

 




Updated 2018-11-26 09:27