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Phase II Study of CAmizestrant in Resectable Endometrial Adenocarcinoma

ConditionsEstrogen Receptor-positiveEarly Stage Endometrial Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto

About this trial

This is a window of opportunity study designed to provide short duration exposure to camizestrant prior to planned curative intent surgery, with the anticipated benefit of demonstrating target engagement and suppression of ER signalling in ER positive endometrial cancer without delaying standard surgical management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must provide informed consent prior to undergoing any study-specific procedures.

Only female participants aged 18 years or older are eligible for inclusion.

ER positivity equal or greater than 10%

TP53 wildtype status by IHC.

Disqualifiers

Participants must not have received any previous systemic or local treatment for the new primary endometrial cancer currently under investigation. This includes surgery, radiotherapy, cytotoxic treatments, and endocrine therapies.

Use of sex-hormone-containing drugs within one month prior to the first dose of study treatment and concurrent use of hormonal treatments (such as for menopausal symptoms).

Medicinal products that are sensitive substrates (e.g. omeprazole) or substrates with narrow therapeutic index of CYP2C9 and/or CYP2C19 (e.g. warfarin and phenytoin) should be stopped at least 2 weeks before the first dose of camizestrant.

Strong CYP3A4/5 inducers (e.g. carbamazepine ) should be should be stopped at least 2 weeks before the first dose of camizestrant (3 weeks for St John's Wort)

Trial design

Design model

Single group

Treatments tested in this trial

  • Camizestrant

    Drug

    Camizestrant is an oral selective ER antagonist and degrader

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CamizestrantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Absolute change in in ER expression by H-score

Time frame
2 years
2

Percentage change in ER expression by H-score

Time frame
2 year

Secondary outcomes

1

Absolute change in in PR expression by H-score

Time frame
2 years
2

Percentage change in PR expression by H-score

Time frame
2 years
3

Absolute change in Ki-67 by IHC scoring

Time frame
2 years
4

Percentage change in Ki-67 by IHC scoring

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: