About Bionomics' Clinical Trials

CURRENT TRIALS

BNC105: Renal Cancer Study (Phase I / II)

A Phase I / II study of BNC105 in combination with everolimus or following everolimus for progressive metastatic renal cell carcinoma (RCC).

A trial to evaluate the combination of BNC105 and everolimus for the therapy of progressive clear cell RCC following prior treatment with Tyrosine Kinase Inhibitor(s) will be begin in 2010. If the combination is feasible, a randomised Phase II trial will be conducted comparing everolimus alone with everolimus plus BNC105. Additionally, patients progressing on everolimus alone will be offered BNC105, which will provide an opportunity to evaluate the activity of monotherapy with BNC105.

  • Patients administered BNC105 will be treated in repeating 21-day cycles, each cycle consisting of two doses administered one week apart (ie on days 1 and 8)
  • Everolimus is orally administered as a 10 mg tablet once a day
  • The trial will open in up to 12 US-based investigative sites and will conducted by the Hoosier Oncology Group
  • The trial is being run under a US FDA Investigational New Drug application

Endpoints:

  • PRIMARY
    • Improvement in six month Progression Free Survival (PFS) with the addition of BNC105 to everolimus
  • SECONDARY
    To determine:
    • Response rate with combination therapy compared to everolimus alone
    • PFS with BNC105 alone in patients progressing on everolimus
    • The adverse events of the everolimus and BNC105 when administered as a combination or sequential regimen
    • Overall survival
  • EXPLORATORY
    • To determine the correlation of PFS with biomarkers

BNC105: Malignant Pleural Mesothelioma Study (Phase II)

A Phase II trial of BNC105 as second line chemotherapy for advanced malignant pleural mesothelioma (MPM).

A trial to investigate the efficacy of BNC105 for the treatment of MPM will begin in the first half of 2010. The trial will open in multiple sites across Australia and will be conducted by the Australasian Lung cancer Trials Group (ALTG).

  • Patients will be treated with BNC105 as monotherapy in repeating 21-day cycles, each cycle consisting of two doses administered one week apart (ie on days 1 and 8)
  • The trial is a single arm Phase II study. Patients enrolled in the study are to receive BNC105 as monotherapy
  • The trial is intended for patients with the pleural form of mesothelioma whom have progressed on the current standard of care (pemetrexed and a platinum agent)
  • Treatment will continue until disease progression or toxicity mandate cessation of therapy

Endpoints

  • PRIMARY
    • To determine the objective tumour response rate according to RECIST modified criteria for mesothelioma
  • SECONDARY
    To determine:
    • Progression-free survival
    • Treatment duration
    • Adverse events
    • Health-related quality of life status
    • Changes in spirometric lung function tests
    • Overall survival

 

COMPLETED TRIALS

BNC105: A Dual Action Vascular Disruption Agent for the Treatment of Solid Tumours (Phase I)

  • A two-stage, open-label, dose-escalation study in patients with advanced solid tumors for whom no standard therapy is available
  • Patients were treated with BNC105P (the pro-drug form of BNC105) as monotherapy in two 21-day cycles, each cycle consisted of two doses administered one week apart (ie on days 1 and 8). The safety, tolerance, and the pharmacokinetics of BNC105 in these patients was determined
  • Patients were treated at four investigative sites in a trial conducted through Cancer Trials Australia
  • The trial was conducted under a US FDA Investigational New Drug application

Endpoints:

  • PRIMARY
    • To determine the safety and maximum tolerated dose of BNC105 in patients with advanced solid tumours
  • SECONDARY
    • To determine the pharmacokinetics of both BNC105 and BNC105P
    • To determine modulation of parameters directly related to vascular characteristics within tumours using DCE-MRI
    • To obtain data on suppression of tumour growth using standard imaging techniques
    • To evaluate prospective biomarkers of response

BNC210: An Improved Anxiolytic for the Treatment of Acute and Generalised Anxiety Disorders

  • The trial followed a double-blind, placebo-controlled, dose-escalation study design in healthy volunteers. There were eight cohorts of four participants each (32 participants in total). Three participants in each cohort received drug and one was given placebo
  • The drug was given orally as a liquid suspension
  • The healthy volunteers were dosed at the Pain and Anaesthesia Research Clinic (PARC) at the Royal Adelaide Hospital
  • The trial was conducted under the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme

Endpoints:

  • PRIMARY
    • To determine the general safety and clinical tolerability of ascending single doses of BNC210
    • To determine the pharmacokinetics of BNC210
  •  SECONDARY
    • To determine the effects of BNC210 on neurological and psychiatric symptoms using Bond and Lader visual analogue scales
    • To identify a dose range to be used in subsequent trials




For Further Clinical Trial Information

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