Stage & Timeline

PENAO-01 clinical trial

Completed

Safety Profile

  • Maximum Tolerated Dose not reached
  • Only one related Dose Limiting Toxicity (fatigue)

Efficacy RESULT

  • Patient with anaplastic astrocytoma had stable disease at 6 mg/m2/day over 10 cycles (30 weeks).
  • 26 patients enrolled with advanced solid tumours at three clinical trial sites in Australia
  • Eight dose levels investigated
  • Last Patient Last Visit 2016

Efficacy RESULT

PENAO-02 clinical trial objectives

  1. To define a therapeutic dose of PENAO in patients with advanced solid tumours.
    • A key conclusion from PENAO-01 is to move from Continuous IV Dosing to a Twice-Weekly regimen.
    • However, the protocol could provide flexibly that other dose schedules may be explored pending review of safety and PK/PD data. Potential for intra- or inter-patient flexibility to aid patient recruitment and retainment.
    • Data to-date suggests PENAO followed by combination therapy may be more effective. However, Recommended Phase Two Dose (RPTD) is not defined and PENAO could have potential as a stand-alone treatment.
  2. To generate useful safety, tolerability and efficacy data of use to clinicians, regulatory authorities, patients and industry.
  3. To inform additional studies within the clinical trial programme.

PENAO-02 clinical trial design

Proposed design of this Phase I/II study is a standard 3+3 oncology trial consisting of two parts: Escalation and Expansion.

Multiple combination therapies and cancers will be explored in the PENAO clinical trial programme.  In the PENAO-02 dose-finding study:

  • It is anticipated that up to 50 patients with Breast Cancer or Non-Small Cell Lung Cancer (NSCLC) would receive PENAO in hospitals across Australia and China.
  • Combination therapies would be everolimus (Breast Cancer) and gefitinib (NSCLC) which is supported by peer-reviewed scientific data.

Clinicaltrials.gov data shows Elli Lilly, AstraZeneca, Hoffman La Roche and Yuhan Corporation have active studies in Breast Cancer (their IMP + everolimus) or NSCLC (their IMP + gefitinib) in Australia (+China). 

Timelines

  • Subject to investment, governance, law, contracts, RA/CA and EC/IRB, third-party activities (eg. Drug Substance and Drug Product manufacture), global and local events, and force majeure.
  • Proposed pediatric clinical trial additionally subject to current drug supply.
  • Projections are estimated from receipt of funds into PENAO Pty Ltd.