Phase 2 Prostate Cancer Trial, Recruiting NCT04606446 Sponsor: Pfizer Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT04606446
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with locally advanced or metastatic breast cancer that is oestrogen receptor-positive and HER2-negative (ER+HER2-), castration-resistant prostate cancer, or non-small cell lung cancer that has not responded to or cannot tolerate standard treatments (Part 1A only)
  • People with locally advanced or metastatic ER+HER2- breast cancer whose disease has continued to grow after at least one prior hormone therapy and one CDK4/6 inhibitor treatment (Parts 1B, 1C, 1D, 1E)
  • People with locally advanced or metastatic ER+HER2- breast cancer who have previously received at least one CDK4/6 inhibitor and at least one hormone therapy (Parts 2A, 2B, 2D, 2E — specific treatment history requirements vary by part; confirm with trial site)
  • For Parts 2B, 2D, and 2E: people who have received no more than three prior systemic treatments in total, including no more than one chemotherapy given for cancer that has spread to organs; prior treatment with fulvestrant is allowed but not required
  • People with ER+HER2- breast cancer whose tumour tests show at least 1% of cells are oestrogen receptor-positive, based on the most recent tumour sample
  • People with ER+HER2- breast cancer whose tumour tests confirm HER2-negative status using standard laboratory methods (confirm with trial site)
  • Women with ER+HER2- breast cancer who are of childbearing potential (or have had only a tubal ligation) and are willing to receive an approved medication to suppress ovarian function (such as goserelin or leuprolide)
  • Women with ER+HER2- breast cancer who are post-menopausal and meet at least one recognised criterion for post-menopausal status (confirm with trial site)
  • People who have at least one measurable area of disease that has not previously been treated with radiation, as defined by standard measurement guidelines (RECIST v1.1)
  • People who are in reasonably good general health, rated as performance status 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
  • People aged 18 years or older (20 or older in Japan; 19 or older in South Korea)
  • People whose kidneys, liver, and bone marrow are functioning adequately based on blood tests
  • People who have recovered from the side effects of any previous cancer treatment to an acceptable level

Who may not be able to join:

  • People with severe fluid build-up in the abdomen that cannot be controlled medically (some people with manageable fluid may still be considered, subject to review by the trial's medical team)
  • People who have had another active cancer diagnosis within the past three years, except for certain treated skin cancers or early-stage cancers that have not spread
  • People who have had major surgery, radiation therapy, or systemic cancer treatment within three weeks before joining the trial
  • People who have previously had radiation to more than 25% of their bone marrow
  • People with certain heart rhythm or electrical abnormalities detected on an ECG, including a QTc interval over 470 milliseconds, certain types of heart block, or signs of a heart attack or active heart muscle problems
  • People who are on full anticoagulation (blood-thinning) treatment — low molecular weight heparin is permitted; some other blood thinners may be allowed after discussion with the trial sponsor (confirm with trial site)
  • People with a known or suspected allergy or serious sensitivity to the study drug (PF-07248144) or any of its ingredients
  • People with active inflammatory bowel disease, ongoing uncontrolled chronic diarrhoea, or a history of stomach or intestinal surgery (such as gastric bypass or lap band surgery) that could affect how the study drug is absorbed; treated acid reflux (GORD) is permitted
  • Women who are pregnant or currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Pfizer CT.gov Call Center, Pfizer

Phone: 1-800-718-1021

Australian sites

Chris O'Brien Lifehouse, Camperdown, New South Wales
Cancer Research South Australia, Adelaide, South Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria
Royal Melbourne Hospital, Parkville, Victoria
Western Health-Sunshine & Footscray Hospitals, St Albans, Victoria
St. John of God Subiaco Hospital, Subiaco, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
16 November 2020
Est. completion
13 July 2029

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇯🇵 Japan 🇰🇷 South Korea 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of participants with dose-limiting toxicities in the Dose Escalation Arms.; Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms.; Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Escalation Arms.; Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion Arms; Safety and Tolerability through monitoring of laboratory assessments for participants enroled in the Dose Expansion Arms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov