Clinical Trials

Beginning its life as Nilai Cancer Institute in 1999, Nilai Medical Centre has a long history in research. Over the years we developed into a multi-disciplinary hospital, but our heritage in research continues in the form of NCI Clinical Trial and Research Centre.

Research produces new medical knowledge and treatment. Our heritage and our contribution to the advancement of the medical field leads to newer and better treatment for patients. It is also our belief a hospital with research activities will provide better services as well, because the doctors continue to update themselves with the latest knowledge as the direct result of having on-going research.

In most parts of the world, research that involves human beings is closely monitored and held to the highest ethical standards. Clinical research need to be approved by the Ethics Committee.  The responsibility of an ethics committee is to safeguard the interest of the patients. A research proposal will need to demonstrate to the Ethics Committee that it can benefit humankind and does not cause unnecessary harm or risk to the participants before it can even start. The research in this hospital is approved by the Medical and Research Ethics Committee of the Ministry of Health, which is independent from us and therefore practise the most optimum neutrality. As usual, participation in research is entirely voluntary and patients exercise the right to withdraw.

Research is from bench to bedside. Here, we do not only do clinical research. We collaborate in basic biomedical research as well.  We are also involved in performance measurements. Performance measurements are increasing in its importance, and play a crucial role in improving the quality of health services.


Some of our research activities...

No Research Year Completed
1 A Phase III Randomized , Double- Blind. Parallel Group, Multicentre study to compare the Efficacy , safety , Pharmacokinetics and Immunogenicity between SB3( proposed trastuzumab biosimilar ) and Herceptin in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting . On-going
2 A Phase III, Randomized, Double Blind, Dummy-Controlled
Study of ThermoDox® (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in Hepatocellular
Carcinoma (HCC) Using Standardized Radiofrequency Ablation (FRA) Treatment Time ≥ 45
Minutes for Solitary Lesions ≥ 3 cm to ≥ 7 cm
On-going
3 Randomized, Double blind, Placebo-controlled Trial of Z-100 plus Radiation Therapy in Patients with Locally Advanced Cervical Cancer — A Phase III Trial On-going
4 An Open _Label , single arm phase IV study to assess the efficacy and safety of afatinib as second -line therapy for patients with locally advanced or metastatic non-small cell lung cancer(NSCLC) harbouring and EGFR mutation (Dell19 or L858R) who have failed first line treatment with platinum -based chemotherapy. On-going
5 A phase III, multicentre ,randomized, open-label trial to evaluate the survival benefit of panitumumab and best supportive care, compared to best supportive care alone, in subjects with chemorefractory wild type KRAS metastatic colorectal cancer. On-going
6 Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®. 2014
7 A randomized, phase II, multicentre, double blind placebo controlled study evaluating the efficacy and safety of onartuzumab (M7tMab) in combination with either bevacizumab +platinum+paclitaxel or pemetrexed + platinum as first line treatment in patients with stage IIIb or IV non squamous non-small cell lung cancer. 2014
8 A multi center, open-label, randomized phase III study to evaluate the efficacy and safety of erlotinib versus gemcitabine / cisplatin as the first  line treatment for stage IIIB/IV non-small cell lung cancer(NSCLC) patients with mutations in the tyrosine kinases domain of the epidermal growth factor receptor(EGFR) in their tumours. 2014
9 FORTIS- M: a phase  III, randomized, double blind, placebo controlled study of oral talactoferrin in addition to best supportive care to patients with non – small  cell lung cancer who have failed two or more treatment regimens. 2012
10 A randomized, open-label, multicentre, phase III study of epoetin alfa plus standard supportive care versus standard supportive care in anemic patients with metastatic breast cancer receiving first- line standard chemotherapy. 2011
11 An open-label, multicentre randomized phase II trial of combination, gemcitabine and carboplatin chemotherapy in patient with metastatic and recurrent nasopharyngeal carcinoma. 2011
12 A phase III, multicenter, randomized, placebo controlled trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy regimens in subject with previously treated metastaticcancer (RIBBON ). 2011
13 An open label, randomized, parallel group, multicentre, phase III study to assess efficacy, safety and tolerability of gefitinib (IRESSA)(250mg tablet) versus carboplatin/paclitaxel doublet chemotherapy as first line treatment in selected patients with advanced (stage IIIB or IV) non-small cell lung cancer (NSCLC) in Asia (IPASS). 2010
14 A phase II/III trial to assess the safety, immunogenicity and preliminary efficacy of recombinant human EGF-rP64K/montanide ISA 51 vaccine administered to patients with non-small cell lung cancer (NSCLC) after receiving conventional first line chemotherapy. 2010
15 A phase III, Randomized, double-blinded, multi-center study to assess the efficacy of docetaxel (TAXOTERE™) in combination with ZD6474 (ZACTIMA™) versus docetaxel (TAXOTERE™) in combination with placebo in patients with locally advanced or metastatic (Stage IIIB – IV) non-small cell lung cancer (NSCLC) after failure of 1st line anti-cancer therapy.  2010
16 A randomized 2 arm, open-label, phase II study of BMS 582664, administered orally at a dose of 800mg daily or doxorubicin administered intravenously at a dose of 60mg/m2 every 3 weeks in patients with unresectable, locally advanced or metastatic hepatocellular carcinoma. 2009
17 A randomized, parallel group, open-label, active controlled, multicentre Phase III trial of patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil®/Caelyx®) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer (CEPO906A2303) EXTEND STUDY. 2008
18 A phase III trial of novel epothilone BMS-247550 plus capcitabine versus capcitabine alone in patients with advanced breast cancer previously treated with or resistant to an antracycline and who are taxane resistant. 2008
19 A multicenter, single-arm, phase II study single-agent vinflunine in the second-line treatment of patients with gastric cancer. 2007
20 A randomized, open label, parallel group, international, multicenter, phase III study of oral ZD1839 (IRESSA) versus intravenous docetaxel (TAXOTERE) in subjects with locally advanced or metastatic recurrent non-small cell lung cancer who have previously received platinum based chemotherapy (INTEREST). 2007
21 A phase III randomized, stratified, parallel-group, multi-centre, comparative study of ZD1839(Iressa) 250mg and 500mg versus methotrexate for previously treated patients with squamous cell carcinoma of head and neck (IMEX). 2007
22 A double blind, placebo controlled, parallel group, multicentre, randomised, phase III survival study comparing ZD1839 (IRESSATM) (250mg tablet) plus best supportive care versus placebo plus best supportive care in patients with advanced NSCLC who have received one or two prior chemotherapy regimes and are refractory or intolerant to their most recent regime. 2004
23 A randomised, double-blind, placebo controlled, multicentre, phase III study of Tarceva plus chemotherapy (cisplatin and gemcitabine) versus chemotherapy alone in patients with advanced (stage III or IV) non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. 2004
24 Patient attitude and lung cancer survival: prospective observational study in advanced non-small cell lung cancer. 2003
25 A study comparing the pharmacokinetic profile of Schering-Plough rHuGM-CSF (Leucomax) with GeneMedix rHuGM-CSF (Neustim), and evaluating the therapeutic efficacy of Neustim, in patients diagnosis with breast cancer undergoing chemotherapy. 2002
26 An open prospective study of imaging by Iodine-131 labelled chimeric antibody, derived from super-high affinity sheep monoclonal antibodies (SMAs) of carcinoembryonic antigen (CEA), in post-surgical patients diagnosed with metastatic colorectal carcinoma. 2000


Healthcare Performance

No Research Year Completed
1 Healthcare Performance Measurement (HPMRS) for breast cancer services in the population.
- Worldwide, healthcare performance measurement is increasingly emphasized. Performance of healthcare organizations will no longer be measured solely by financial parameters. More and more stakeholders are investing in measuring the quality of care, which is what matters most in health.
We were one of the 8 hospitals which participated in this pioneering project in Malaysia, with Dr R. Kananathan as the principal investigator. You can read about the news report here and find the results here .
On-going
2 Healthcare Performance Measurement (HPMRS) for lung cancer services in the population. On-going


Research Collaboration in Nasopharyngeal Carcinoma

No Research Year Completed
1 Isolation, characterization and functional analysis of cancer stem cells from nasopharyngeal carcinoma.
- collaboration with International Medical University
2011
2 Validation of biomarkers for diagnosis and therapy of nasopharyngeal carcinoma.
-collaboration with Cancer Research Initiatives Foundation (CARIF)
2008
3 Association of selected candidate genes and nasopharyngeal carcinoma.
-collaboration with University of Malaya
2007
4 Nasopharyngeal carcinoma: roles of Epstein-Barr virus latent proteins in invasion and metastasis.
-collaboration with International Medical University and University Malaya
2006


Our consultants with on-going research activity at the moment

Dr. R.Kananathan 
Medical Oncologist
MBBS (Mal), LRCPI, MRCP (Ire), FRCP (Ire), AM (Mal)

Dr Kananathan, who has been practicing in this hospital since the year 2000 was very much ingrained in the fabric of clinical research. He has participated in 23 completed clinical studies to date, 19 of them in oncology. His name had appeared in about 80 presentations and 15 publications.

Dr. Chandrashekar Hospet 
Clinical Oncologist
MBBS (India), MD (India), DNB

Before joining this hospital, Dr. Chandrashekar has practiced and lectured in a few places in India and Malaysia. He has a special interest in working on precision radiation therapy and had participated in 4 investigator initiated trials and 3 industry sponsored trials to date.

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Dr Jayendran Dharmaratnam
Clinical Oncologist
MBBS (Mysore),DMRT (London), 
FFR.RCSI (Dublin),DSM (Perth), AM (Malaysia)

Dr Jayendran is a clinical oncologist (Radiotherapy/Medical Oncology) with 30 years’ experience in government medical services. He received his Diploma and Fellowship in Clinical Oncology from UK where he has worked in several cancer centres. He has also been credited with implementing new oncology services in various centres throughout the country. He has also been involved in many clinical research studies, and is an adviser to several health organizations. Presently he is the Person in Charge of Nilai Medical Centre where he also has the responsibility of being the ‘Head of Clinical Research’. His other area of interest is in Sports and Rehabilitation Medicine.
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Dr. Shew Yee Siang
Clinical Oncologist 
MBBS (Malaya),FRCR (UK), MBA (UTAR, Malaysia), 
Clinical Fellowship in Medical & Radiation Oncology (Singapore)

Dr Shew is a clinical oncologist (Radiation/Medical) and also a Master of Business Administration (Health care studies). He is a fellow of Royal College of Radiologist (UK) and has clinical fellowship in Medical & Radiation Oncology (Singapore). Dr Shew have achieved qualification for Good Clinical Practice (GCP,2005) and a have published many medical journal papers through his years of research.
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In order to better support our research activities, we have a dedicated administrative unit with experienced study coordinators and administrator.
They are Ms. Tamilselvi Arumugam, Ms. Satwant Kaur.


For any matters pertaining to clinical trial, you may contact Ms. Satwant Kaur at satwant@nilaimc.com.
Tel. (+6)06-8500 999 or (+6)06-7990 999 ext. 3104.