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

NCT03148795

Last updated date
Study Location
PRP Diagnostic Imaging
Westmead, New South Wales, 2145, Australia
Contact
1-800-718-1021

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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 archival tumor tissue (via central laboratory) or prior historical testing (with Sponsor approval) using the Foundation Medicine, FoundationOne CDx™ 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 from the time of the first dose of study drug through 4 months after last dose of study drug. A highly effective form of contraception must be used from the time of the first dose of study drug through 4 months 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 4 months 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 <=6 months prior to
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. Prior diagnosis of myelodysplastic syndrome or acute myeloid leukemia


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 within 7 days prior to first dose of study drug or
anticipated use during the study 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).


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 sponsor, 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 4 months after the last dose of investigational product.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE TALAPRO-1: A PHASE 2, OPEN-LABEL, 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)
Brief Summary The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: Talazoparib
1 mg daily
Other Name: MDV3800
Study Arms  ICMJE Experimental: Talazoparib
Talazoparib 1 mg daily
Intervention: Drug: Talazoparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2017)
150
Estimated Study Completion Date  ICMJE March 2, 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 archival tumor tissue (via central laboratory) or prior historical testing (with Sponsor approval) using the Foundation Medicine, FoundationOne CDx? 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 ?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.
  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 from the time of the first dose of study drug through 4 months after last dose of study drug. A highly effective form of contraception must be used from the time of the first dose of study drug through 4 months 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 4 months 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:

  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 <=6 months prior to 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. Prior diagnosis of myelodysplastic syndrome or acute myeloid leukemia
  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 within 7 days prior to first dose of study drug or anticipated use during the study 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).
  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 sponsor, 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 4 months after the last dose of investigational product.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT03148795
Other Study ID Numbers  ICMJE MDV3800-06
C3441006 ( Other Identifier: Alias Study Number )
2016-002036-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP