Stage & Timeline
PENAO-01 clinical trial
PENAO-02 clinical trial objectives
- 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.
- To generate useful safety, tolerability and efficacy data of use to clinicians, regulatory authorities, patients and industry.
- 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).