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A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. At least 18 years of age.

2. Histologically or cytologically confirmed adenocarcinoma of the prostate without
signet cell, or small cell features.

3. Patients must have measurable soft tissue disease per RECIST 1.1

4. DNA damage repair deficiency as assessed centrally by a gene mutation biomarker panel
(testing of de novo or archiaval tumor tissue (via central laboratory) or prior
historical testing (with Sponsor approval) using the Foundation Medicine,
FoundationOne® NGS gene panel test.

5. Consent to a saliva sample collection for a germline comparator, unless prohibited by
local regulations or ethics committee (EC) decision.

6. Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.

7. Bilateral orchiectomy or ongoing androgen deprivation therapy with a
gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical
castration).

8. Progressive disease at study entry defined as 1 or more of the following 3 criteria:

- A minimum of 3 rising PSA values with an interval of at least 1 week between
determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2
ng/mL) if qualifying solely by PSA progression.

- Soft tissue disease progression as defined by RECIST 1.1.

- Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions
on bone scan.

9. Metastatic disease.

10. Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based
regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have
received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did
not have access to these therapies.

11. Documented disease progression (either radiographic or biochemical) on at least 1
novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) for the
treatment of metastatic CRPC, irrespective of prior NHT treatment for non castrate
prostate cancer or nonmetastatic (M0) CRPC.

12. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before
day 1 for patients receiving these therapies.

13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

14. Estimated life expectancy of ≥ 6 months as assessed by the investigator.

15. Able to swallow the study drug, have no known intolerance to study drugs or
excipients, and comply with study requirements.

16. Must use a condom when having sex with a pregnant woman from the time of the first
dose of study drug through 105 days after last dose of study drug. An additional
highly effective form of contraception must be used from the time of the first dose of
study drug through 105 days after last dose of study drug when having sex with a non
pregnant female partner of childbearing potential.

17. Must agree not to donate sperm from the first dose of study drug to 105 days after the
last dose of study drug.

18. Patients must be willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. 1. Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal,
biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other
than approved bone targeting agents and GnRH agonist/antagonist) or any other
investigational agent within 4 weeks before day 1.

2. Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone chemotherapy.
Patients who discontinued prior platinum based chemotherapy screening or whose disease previously progressed on platinum based therapy at any time
in the past are also excluded.

3. Treatment with any concurrent cytotoxic chemotherapy or investigational drug(s) within
4 weeks or 5 half lives of the drug (whichever is longer) before Day 1 and/or during
study participation

4. Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy)
before day 1.

5. Major surgery within 2 weeks before day 1.

6. Clinically significant cardiovascular disease.

7. Significant renal, hepatic, or bone marrow organ dysfunction.

8. Known or suspected brain metastasis or active leptomeningeal disease.

9. Symptomatic or impending spinal cord compression or cauda equina syndrome.

10. Diagnosis of MDS (Myelodysplastic syndromes).

11. History of another cancer within 3 years before enrollment 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.

12. Gastrointestinal disorder affecting absorption.

13. Current or anticipated use of the following P gp inhibitors (amiodarone, carvedilol,
clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir,
itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine,
ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar), P gp
inducers (avasimibe, carbamazepine, phenytoin, rifampin, and St. John's wort), or BCRP
inhibitors (curcumin, cyclosporine, elacridar [GF120918] and eltrombopag).

14. Any other acute or chronic medical or psychiatric condition (concurrent disease,
infection, or comorbidity) that interferes with ability to participate in the study,
causes undue risk, or complicates the interpretation of data, in the opinion of the
investigator or medical monitor, including recent (within the past year) or active
suicidal ideation or behavior or laboratory abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for entry into this study.

15. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
patients who are Pfizer employees, including their family members, directly involved
in the conduct of the study.

16. Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 105 days after the last dose of investigational product.

NCT03148795
Pfizer
Recruiting
A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

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A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
A Phase 2, Open-label, 2-arm, Response Rate Study Of Talazoparib In Men With Dna Repair Defects And Metastatic Castration-resistant Prostate Cancer Who Previously Received Taxane-based Chemotherapy And Progressed On At Least 1 Novel Hormonal Agent (Enzalutamide And/or Abiraterone Acetate/Prednisone)
The purpose of this international, phase 2, open-label, 2-arm, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: Talazoparib
1 mg daily
Other Name: MDV3800
Experimental: Talazoparib
Talazoparib 1 mg daily
Intervention: Drug: Talazoparib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 3, 2022
August 2, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least 18 years of age.
  2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features.
  3. Consent to a fresh tumor biopsy before enrollment unless adequate archival tissue is available for molecular analyses.
  4. DNA damage repair deficiency as assessed centrally by a gene mutation biomarker panel.
  5. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
  6. Serum testosterone ? 1.73 nmol/L (50 ng/dL) at screening.
  7. Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).
  8. Progressive disease at study entry defined as 1 or more of the following 3 criteria:

    • A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ? 2 ?g/L (2 ng/mL) if qualifying solely by PSA progression.
    • Soft tissue disease progression as defined by RECIST 1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.
  9. Metastatic disease. Patients with disease spread limited to regional pelvic lymph nodes (below the aortic bifurcation) are not eligible unless bone metastasis is present on bone scan. Patients may also have metastatic disease documented by bone lesions on whole body radionuclide bone scan.
  10. Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
  11. A history of disease progression during previous treatment for metastatic CRPC with at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) in the opinion of the investigator.
  12. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
  13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  14. Estimated life expectancy of ? 6 months as assessed by the investigator.

Exclusion Criteria:

  1. Use of systemic hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
  2. Prior treatment with a PARP (poly ADP ribose polymerase) inhibitor, platinum, cyclophosphamide, or mitoxantrone chemotherapy.
  3. Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
  4. Major surgery within 2 weeks before day 1.
  5. Clinically significant cardiovascular disease.
  6. Significant renal, hepatic, or bone marrow organ dysfunction.
  7. Known or suspected brain metastasis or active leptomeningeal disease.
  8. Symptomatic or impending spinal cord compression or cauda equina syndrome.
  9. Diagnosis of MDS (Myelodysplastic syndromes).
  10. History of another cancer within 3 years before enrollment 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.
  11. Gastrointestinal disorder affecting absorption.
  12. Current or anticipated use of a strong P-gp inhibitor (eg, dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), strong P-gp inducer (eg, rifampin, tipranavir, ritonavir), or strong inhibitor of BCRP (breast cancer resistance protein).l
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No

Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Belgium,   France,   Italy,   Spain,   United Kingdom,   United States
Netherlands
 
NCT03148795
MDV3800-06
C3441006 ( Other Identifier: Alias Study Number )
2016-002036-32 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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