Metastatic Castration-Resistant Prostate CancerNCT05650476
Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)
A study testing Talazoparib in people with Metastatic Castration-Resistant Prostate Cancer, run by Pfizer.
Trial summary
Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- Talazoparib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Talazoparib is not intended for monotherapy. Talazoparib is intended for combination use with enzalutamide in first-line metastatic (M1) Castration-Resistant Prostate Cancer (mCRPC) only. Must be a newly diagnosed mCRPC patient who has not yet received 1st line therapy (1st generation Androgen Receptor (AR)-inhibitors do not count). Must have not received 2nd generation AR-inhibitors (enzalutamide, apalutamide, darolutamide), a Poly [ADP-ribose] polymerase (PARP)-inhibitor, cyclophosphamide, or mitoxantrone as prior treatments in any prostate cancer disease setting. Previous abiraterone and/or docetaxel for hormone-sensitive disease (CSPC) is allowed (patient eligible). Patients with identified need for use of potent P-glycoprotein (P-gp) inducer drugs within 7 days of onset/under duration of talazoparib plus enzalutamide treatment are at risk of drug-drug interactions (DDIs) and are therefore ineligible. Additional eligibility criteria may be required.
Trial locations and contacts
No sites are listed yet.
Pfizer Cares contact
About this study
Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer.
Read the detailed description
In Expanded Access, treating physicians are the Sponsors..
Expanded Access requests from treating physicians may be submitted at www.pfizercares.com; availability will depend on location/country.
- Being tested
- Talazoparib
- Keywords
- Prostate Cancer, metastatic* Castration-Resistant Prostate Cancer (mCRPC), enzalutamide, combination therapy, first-line mCRPC, metastatic (M1)
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalazoparibDrug
capsules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650476
- Sponsor's protocol ID
- C344
- Other IDs
- NCT05650476
- Status last verified
- Jun 2025
- First submitted
- 6 Dec 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)
- ClinicalTrials.gov ID
- NCT05650476
- Acronym / sponsor ID
- C344
- Keywords
- Prostate Cancer, metastatic* Castration-Resistant Prostate Cancer (mCRPC), enzalutamide, combination therapy, first-line mCRPC, metastatic (M1)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer.
Detailed description
In Expanded Access, treating physicians are the Sponsors..
Expanded Access requests from treating physicians may be submitted at www.pfizercares.com; availability will depend on location/country.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talazoparibcapsules | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer Cares contact
Questions about this trial
What is this clinical trial studying?
A study testing Talazoparib in people with Metastatic Castration-Resistant Prostate Cancer, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pfizer Cares (PfizerCares@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.