Research2019-05-03T03:42:51+00:00

Clinical Trials

Tom is involved in many Oncology Clinical Trials run out of St John of God Subiaco Hospital

Publications

Martin, H. L., Ohara, K., Kiberu, A., van Hagen, T., Davidson, A. and Khattak, M. A. (2014), Prognostic value of systemic inflammation-based markers in advanced pancreatic cancer. Intern Med J, 44: 676–682.

Han L.Y., Karavasilis V, van Hagen T, Nicum S, Thomas K, Harrison M, Papadopoulos P, Blake P, Barton D, Gore M, Kaye S.B., Doubling time of serum CA125 is an independent prognostic factor for survival in patients with ovarian cancer relapsing after first-line chemotherapy, European Journal of Cancer , Volume 46 , Issue 8 , 1359 – 1364

George A, Michalarea V, Rafii S, Michie C.O., Wong M, Bowen R, Han L.Y., van Hagen T, Rallis G, Banerji U, Kristeleit R.S., De Bono J.S., Banerjee S.N., Molife

L.R., Gore M.E., Kaye S.B., Yap T.A., Clinical outcomes in advanced cervical cancer (CC) and endometrial cancer (EC) patients (pts) treated in phase I trials of novel molecularly targeted agents (MTAs).J Clin Oncol 33, 2015 (suppl; abstr 5596)

Chua Y.J., Karapetis C.S, Gebski V, O’Connell R, Begbie S, Nott L.M., Cronk M.F., Underhill C, Abdi E.A., van Hagen T, Wong N, Hall M, Ferraro D.A., Sjoquist

K.M., Santos C, Mackey J.R., Goldstein D, Human equilibrative nucleoside transporter 1 (hENT1) in gemcitabine and FOLFOX (oxaliplatin, 5-fluorouracil, and leucovorin)-treated patients with metastatic pancreatic cancer: The randomized phase II PAN1 study. J Clin Oncol 32, 2014 (suppl 3; abstr 228)

Yap T.A, George A, Michie C.O, Wong M, Bowen R, Rafii S, Michalarea V, van Hagen T, Han L.Y., Rallis G, Molife L.R., Banerji U, Kristeleit R.S., Banerjee S.N., De Bono J.S., Gore M.E., Kaye S.B.,What factors influence advanced ovarian cancer patient (AOC pt) outcomes to phase I trial treatments? J Clin Oncol 32:5s, 2014 (suppl; abstr 5560)

Jamil K.M., van Hagen T, Trotter J, Cheng W, Kontorinis N, Acute liver failure in a patient with lung cancer. Gut. 2007;56(9):1190.

Research Roles

Principle Investigator

ASCENT: An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients with Metastatic Colorectal Cancer Treated with Bevacizumab (AvastinTM)

ASCOLT: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers – An International, Multi-centre, Double Blind, Randomised Placebo Controlled Phase III Trial

CHECKMATE 915: A Phase III, randomised, double-blind study of adjuvant immunotherapy Nivolumab (Nivo) combined with Ipilmumab (Ipi) versus Ipilimumab or Nivolumab Monotheray after complete researction of Stage IIIb/c/d or stage IV Melanoma in subjects who are at high risk of recurrence (CA209-915)

CO23: A phase 3 randomized study of BBI608 and best supportive care versus placebo and best supportive care in patients with pretreated advanved colorectal carcinoma

INTEGRATE 1: A Randomised Phase II Double-Blind Placebo-Controlled (2:1) Study of Regorafenib in Refractory Advanced Oesophago-Gastric Cancer (AOGC)

INTEGRATE 2: A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Oesophago-Gastric Cancer (AOGC)

JAVELIN (Merkel Cell): a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).

JAVELIN 2 (Merkel Cell): a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in subjects with metastatic Merkel cell carcinoma (MCC).

NABNEC: A Randomised Phase II Study of nab-paclitaxel in Combination with Carboplatin as First Line Treatment of Gastrointestinal Neuroendocrine Carcinomas

PAN1 study: Human equilibrative nucleoside transporter 1 (hENT1) in gemcitabine and FOLFOX (oxaliplatin, 5-fluorouracil, and leucovorin)-treated patients with metastatic pancreatic cancer.

PETACC-6: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer

OMS-I103 (PISCES): A Multicenter Phase 2, open-label trial of intratumoral PIL-12 plus electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who are progressing on either pembrolizumab or nivolumab treatment

SCOT: Short Course Oncology Therapy – A Randomised Phase III Study of Adjuvant Chemotherapy in Colorectal Cancer[For fully resected high-risk stage II/stageIII colorectal cancer (AGITG)]

Co-Investigator (Recent Trials)

ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study

ACTICCA-1: Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma

APACT: A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

BAYER Basket Studies / ARCS-Multi: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY 94-9343) in Patients with Mesothelin Expressing Advanced or Recurrent Malignancies (Protocol #: BAY 94-9343/ 15834) (NSCLC and TNBC)

BAYER Basket Studies / ARCS-Multi: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY 94-9343) in Patients with Mesothelin Expressing Advanced or Recurrent Malignancies (Protocol #: BAY94-9343/15834) (Gastic/GE Junction, Pancreatic, Cholangiocarcinoma)

CEND1: A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer

DCARE: Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

DENALI: A 3-arm phase 2 double blind randomised study of carboplatin, pemetrexed plus placebo versus carboplatin, pemetrexed plus 1 or 2 truncated courses of demcizumab in non-squamous NSCLC

DUBLIN 3 Randomized blinded Phase 3 Assessment of Second-or Third Line Chemotherapy with Docetaxel + Plinabulin Compared to Docetaxel alone+ placebo in Patients with Advanced Non-Small Cell Lung Cancer with at Least 1 Large Lung Lesion (DUBLIN-3)

IMPASSION: A phase 3, multicentre, randomized, placebo-controlled study of MPDL3280A (Anti-PD-L1 antibody) or placebo in combination with NAB-paclitaxel for patients with previously untreated metastatic triple-negative breast cancer

KEYNOTE 181: A Randomized Open-label Phase III Study of Single Agent Pembrolizumab vs Physicians’ Choice of Single Agent Paclitaxel or Docetaxel in Subjects with Advanced/Metastatic Squamous Cancer and Adenocarcinomas of the Esophagus that have Progressed after First-Line Standard Therapy

KEYNOTE 177: A Phase III study of Pembrolizumab (MK3475) vs. chemotherapy in microsatellite instability high (MSI) or mismatch repair deficient (dMMR) stage IV colorectal carcinoma

NAPOLI 1: A randomised, Open Label Phase III Study of MM-398, versus 5-Fluorouracil and Leucovorin, in Patients with Metastatic Pancreatic Cancer who have Failed Prior Gemcitabine-based Therapy

NAPOLI 2: Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

OPAL Lung: Online and Phone Assistance in Lung cancer (previously Helpline study)

RANGE: A randomised, double-blind, placebo controlled, phase 3 study of ramucirumab/placebo plus docetaxel in locally advanced or unresectable or metastatic urothelial carcinoma who progressed on or after platinum based therapy.

STORM: A phase 1, dose-finding and signal seeking study of the safety and efficacy of intravenous cavatak (coxsackievirus A21, CVA21) alone and in combination with pembrolizumab in patients with late stage solid tumours (NSCLC, prostate cancer, melanoma and bladder cancer) – PART B (Dose expansion) Protocol no. VLA-009

TACTI-002 (Two ACTive Immunotherapeutics): A multicenter, open label, Phase II study in patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC), or recurrent PD-X refractory NSCLC or with recurrent or metastatic squamous head and neck cancer (HNSCC) receiving the soluble LAG-3 fusion protein eftilagimod alpha (IMP321) in combination with pembrolizumab (PD-1 antagonist)

TRITON 2 (CO-338-052): A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer Associated
with Homologous Recombination Deficiency

TRITON 3 (CO-338-063): A Multicenter, Randomized, Phase 3 Study of Rucaparib versus Physician’s Choice as 2nd Line Treatment Following Androgen Receptor Directed Therapy for Patients with Metastatic Castration-Resistant Prostate Cancer Associated with a Deleterious BRCA or ATM Mutation.

YOSEMITE: A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane Plus Placebo versus Gemcitabine, Abraxane plus 1 or 2 Truncated Courses of Gemcitabine, Abraxane® plus 1 or 2 Truncated Courses of Demcizumab in Subjects with 1st-line Metastatic Pancreatic Ductal Adenocarcinoma.

Learn more about Research at SJOG Subiaco Hospital