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Prostate CancerPhase 1/2NCT04019327

A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

A Phase 1/2 study testing Talazoparib and Temozolomide in people with Prostate Cancer and Prostate Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Talazoparib and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
9 sitesUnited States
Study dates
11 Jul 2019to 4 Dec 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information or have their legally authorized representative provide written informed consent. A signed informed consent must be obtained prior to performing screening procedures.
  • NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
  • Males 18 years of age or above
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Bilateral orchiectomy or ongoing androgen deprivation therapy with a GnRH agonist/antagonist (surgical or medical castration)
  • Progression of mCRPC on treatment with at least 1 second generation hormonal agent (e.g., enzalutamide and/or abirateroneacetate/prednisone)
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  • Documented progressive mCRPC based on at least one of the following criteria:
  • PSA progression defined as at least 2 rises in PSA with a minimum of a 1-week interval
  • 1.0 ng/mL is the minimal starting value if confirmed rise is only indication of progression
  • Soft-tissue progression per RECISTv1.1
  • Progression of bone disease (evaluable disease) or tow or more new bone lesions by bone scan
  • Metastatic disease documented by bone lesions on whole-body radionuclide bone scan or soft tissue disease by computed tomography/magnetic-resonance imaging (CT/MRI).
  • Consent to a fresh tumor biopsy during screening or have sufficient archival tumor tissue available for molecular profile and biomarker analyses
  • ECOG status of 0 or 1 (Appendix A: Performance Status Criteria)
  • Serum testosterone </= 50mg/dL at screening
  • Adequate organ function with acceptable initial laboratory values within 14 days of treatment start:
  • Absolute neutrophil count (ANC): >/= 1,500/ul Hemoglobin: >/= 9g/dL Platelet count: >/= 100,00/ul Creatinine: >/= 60 mL/min estimated using the Cockcroft-Gault equation Potassium: >/= 3.5 mmol/L (within institutional normal range) Bilirubin: </= 1.5 ULN (unless documented Gilbert's disease) SGOT(AST): </= 2.5 x ULN SGPT (ALT): </= 2.5 x ULN
  • Patients must agree to use a highly effective method of contraception (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence during treatment, and for at least 7 months after completing therapy. Furthermore, male patients with female partners of reproductive potential and pregnant partners must use a condom (even after vasectomy), during treatment and for at least 4 months after the final dose. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrio contraception unless postmenopausal or abstinent.

Who cannot join

  • Prior treatment with a taxane-based chemotherapy for mCRPC (prior treatment with a taxane-based chemotherapy for metastatic non-castrate prostate cancer is permitted)
  • Prior treatment with a PARP inhibitor, platinum, cyclophosphamide, mitozantrone chemotherapy, ortemozolmide
  • Patient has received radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) of treatment start
  • Documented carrier of a pathogenic or likely pathogenic germline or somatic mutation in BRCA 1, BRC 2 or ATM or known carrier (pathogenic or likely pathogenic) or one of the following DNA Damage Repair genes considered as sensitizing tumors to PARP inhibitors: FANCA, CHECK2, PALB2, MRE11A, NBN, RAD51C, ATR, MLH1, and CDK12. Testing is required for BRCA 1, BRCA 1, or ATM. If a patient has had next generation sequencing that did not include FANCA, CHECK2, PALB2, MRE11A, NBN, RAD51C, ATR, MLH1, or CDK12 he will not be excluded from the study if status is unknown.
  • Note, if testing is germline negative, somatic testing is still required. If the patient is germline positive, the patient is ineligible.
  • Use of systemic hormonal (except for GnRH analog), biologic, radium-223, or any investigational therapy for treatment of metastatic prostate cancer within 4 weeks prior to treatment start. Exceptions include abiraterone, which may not have been administered within 2 weeks of treatment start.
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  • Use of Lutetium (177Lu) vipivotide tetraxetan within 4 weeks prior to treatment start.
  • Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, or cardiac disease that would, in the opinion of the investigator, make this protocol unreasonably hazardous to the patient.
  • Known or suspected brain metastasis or active leptomeningeal disease.
  • Symptomatic or impending spinal cord compression or cauda equine syndrome
  • Diagnosis of myelodysplastic syndrome (MDS)
  • History of another cancer within 2 years of treatment start with the exception of nonmelanoma skin cancers or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the Sponsor
  • Use of any prohibited concomitant medications (Appendix C: Medications With the Potential for Drug-Drug Interactions) within 14 days prior to the first dose of talazoparib
  • Grade > 2 treatment-related toxicity unresolved from prior therapy
  • Known allergy to any of the compounds under investigation
  • Any other condition which, in the opinion of the investigator, would preclude participation in this trial

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Lehigh Valley Health Network (Data Collection Only)

    Allentown, Pennsylvania, 18103

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Memorial Sloan Kettering Commack (Limited protocol activity)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase Ib/II Study of Intermittent Talazoparib Plus Temozolomide in Patients With Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair

The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer.

The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose.

Being tested
Talazoparib, Temozolomide
Keywords
talazoparib, temozolomide, Prostate cancer, Memorial Sloan Kettering Cancer Center, 19-041
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalazoparibDrug

    Also called Tala

    Phase I maximum tolerated dose portion:

    Level 1, 2, 3 - 1 mg QD Days 1-6 Level 4, 5 - 1.25 mg QD Days 1-6 Level 6 - 1.5 mg QD Days 1-6

  • TemozolomideDrug

    Also called TMZ

    Phase I maximum tolerated dose portion:

    Level 1 - 37.5 mg/m2 QD Days 2-8 Level 2 - 75 mg/m2 QD Days 2-8 Level 3 \& 4 - 100 mg/m2 QD Days 2-8 Level 5 \& 6 - 125 mg/m2 QD Days 2-8

Study groups in NCT04019327
Study groupRoleWhat they receive
Metastatic Castration Resistant Prostate CancerExperimentalParticipants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair
Receives: Drug: Talazoparib; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Number of Toxicities From Participants Evaluated for Treatment-Emergent Adverse Events/Toxicities [Safety and Tolerability])

    Toxicities will be classified by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0).

    Measured: 30 days after last dose of study treatment (+/- 3 days), up to 1 year

  2. Phase II: Overall Response Rate

    Overall best response rate (confirmed Complete Response/CR or Partial Response/PR) will be calculated according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 30 days after last dose of study treatment (+/- 3 days), up to 1 year

  3. Phase II: Number of Participants With Reduction in PSA Level of 50% or More Compared to Baseline

    Reduction in PSA level of 50% or more compared to baseline as the best PSA response

    Measured: 30 days after last dose of study treatment (+/- 3 days), up to 1 year

  4. Phase II: Number of Participants With Circulating Tumor Cell (CTC) Response

    CTC/Circulating tumor cell zero count, which is indicated as a reduction in the number of CTCs from 1 or more per 7.5 mL of blood at baseline to 0 per 7.5 mL during treatment using the CellSearch platform

    Measured: 30 days after last dose of study treatment (+/- 3 days), up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start11 Jul 2019
  3. Primary completion4 Dec 2025
  4. Study completion4 Dec 2025

Why it stopped: Study terminated by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04019327
Sponsor's protocol ID
19-041
Status last verified
Dec 2025
First submitted
11 Jul 2019
Last updated
24 Aug 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Autio KA, Kyriakopoulos CE, Palyca P, Xiao H, Emamekhoo H, Danila D, Jan M, Catharine V, Riedel E, Devitt M, Laird AD, Scher HI. A phase 1b/2 study of intermittent talazoparib plus temozolomide in patients with metastatic castration-resistant prostate cancer and no mutations in DNA damage response genes. Invest New Drugs. 2025 Aug;43(4):924-932. doi: 10.1007/s10637-025-01580-1. Epub 2025 Sep 4.

    PubMed 40906325

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Talazoparib and Temozolomide in people with Prostate Cancer and Prostate Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. 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: stopped early, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Number of Toxicities From Participants Evaluated for Treatment-Emergent Adverse Events/Toxicities [Safety and Tolerability]) (time frame: 30 days after last dose of study treatment (+/- 3 days), up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019327, which also lists 1 linked publication.

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 24 Aug 2026.

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