The XPORT-EC-042 study is open to recruitment in Australia, after Border Medical Oncology Research Unit and Peter MacCallum Cancer Centre were activated.

The trial is led by Karyopharm Therapeutics (Global Sponsor), in collaboration with ANZGOG, European Network of Gynaecological Oncological Trial Groups (ENGOG) and GOG Foundation.

XPORT-EC-042 is led by Coordinating Principal Investigators A/Prof Yoland Antill and Dr. Kate Webber in ANZ, and aims to recruit 40 ANZ patients (220 globally) and open at 15 sites across Australia and New Zealand.

XPORT-EC-042’s Principal Investigators

Associate Professor Yoland Antill

Medical Oncologist, VIC

Dr Kate Webber

Medical Oncologist, VIC

Why is XPORT-EC-042 needed?

There has been a concerning global rise in the incidence rates of endometrial cancer (which accounts for 90-95% of all uterine cancer cases). In Australia, case numbers have doubled over the last 20 years, whilst in New Zealand numbers have trebled. Despite the average age of diagnosis being 63 years, there is a concerning uptick in cases among women under 50 years old. The prognosis for advanced and recurrent endometrial cancer, marked by limited disease control post-first-line systemic treatment, underscores the urgent need for better treatment options.

What is XPORT-EC-042 investigating?

In response to the growing complexity of managing endometrial cancer, the XPORT-EC-042 trial aims to evaluate the benefit of selinexor in patients with no P53 alteration in advanced or recurrent endometrial cancer. Patients will receive either oral selinexor or placebo as maintenance therapy following chemotherapy, until disease progression.

Following Karyopharm’s SIENDO study which demonstrated a subgroup of patients with P53 wild-type (wt) had better outcomes with the use of maintenance selinexor following chemotherapy, XPORT-EC-042 is a global, Phase III study that plans to enrol up to 220 patients with P53 wt. The tumour suppressor protein TP53 wt plays various critical anti-cancer functional roles in the cell. For endometrial cancer patients that have P53 wt, selinexor plays a role in inhibiting parts of the cell cycle resulting in cancer cell death. Approximately 50% of advanced/recurrent endometrial cancers are P53 wt. The XPORT-EC-042 study will randomise patients 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression. The primary endpoint of the study is progression free survival, with overall survival as a key secondary endpoint.

Eligibility criteria

The trial may be suitable for women with P53 wild-type advanced or recurrent endometrial acncer who have completed at least 12 weeks of platinum-based therapy with or without immunotherapy and achieved confirmed partial or complete response. 

It is advisable that patients discuss their concerns and the best course of action regarding their participation in clinical trials with their oncologist. 

Where will XPORT-EC-042 be available?

  • Monash Health (Lead Site for NMA HREC)
  • Chris O’Brien Lifehouse
  • Central Coast Local Health District (Gosford Hospital & Wyong Hospitals)
  • Royal Hobart Hospital
  • Cabrini Health Oncology (Cabrini Malvern & Cabrini Brighton)
  • Frankston Hospital
  • Peter MacCallum Cancer Centre
  • Newcastle Private Hospital
  • Toowoomba Hospital
  • Border Medical Oncology Research Unit
  • Box Hill Hospital – Eastern Health (Oncology)
  • ICON Cancer Centre Southport
  • The Royal Adelaide Hospital
  • Westmead Hospital
  • Auckland City Hospital

Patient referrals to XPORT-EC-042

We encourage referrals to this study via medical professionals. Please contact the Clinical Trial Project Manager at XPORT@anzgog.org.au for more information.

For more information on the participation criteria please visit here.

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