A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

NCT02836028

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
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

- Women ≥ 18 years of age and willing and able to provide informed consent

- Relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. Histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma.

- Sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. Consent to blood sample collection for biomarker analysis is required.

- Disease progression per RECIST 1.1 during or after the last treatment. Have metastatic disease with at least 1 target tumor lesion measurable per RECIST 1.1 on the screening scan. Lesions used for biopsies cannot be designated as a measurable lesion for RECIST 1.1 assessments.

- Additional criteria for cohort 1 include the following:

- Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ≥ 42), which represents a loss of DNA repair function based on testing performed at a sponsor-approved laboratory

- Received at least 1 and no more than 3 platinum-based chemotherapy regimens (prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization

- No prior PARP inhibitor treatment (COHORT 1 ONLY)

- Additional criteria for cohorts 2 and 3 include the following:

- Received at least 2 platinum-based chemotherapy regimens (including first-line chemotherapy; prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization

- Received prior PARP inhibitor treatment as a single agent or in combination therapy regimen and the last dose is ≥ 28 days before randomization, as follows:

- For cohort 2 only: Received PARP inhibitor treatment for ≥ 6 months and had a response of CR, PR, or stable disease for ≥ 6 months

- For cohort 3 only: Received PARP inhibitor treatment for < 6 months with no response (disease progression or stable disease)

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

- Estimated life expectancy of ≥ 3 months.

- Able to swallow drugs, have no known intolerance to study drugs or excipients, and able to comply with study requirements.

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


- Have not recovered (recovery is defined as National Cancer Institute Common
Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities
of previous therapy, except treatment-related alopecia or laboratory abnormalities
otherwise meeting eligibility requirements.


- Use of any investigational agent within 14 days before randomization.


- Had > 2 paracentesis procedures within 28 days before randomization.


- Major surgery within 14 days before randomization.


- Requirement for intravenous alimentation (at the time of randomization).


- Diagnosis of MDS.

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  188. Toon, Ehime
  189. Sapporo, Hokkaido
  190. Akashi, Hyogo
  191. Tsukuba, Ibaraki
  192. Isehara, Kanagawa
  193. Kawasaki, Kanagawa
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  198. Tokorozawa, Saitama
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  200. Shimotsuke, Tochigi
  201. Bunkyo-ku, Tokyo
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  232. Poznan,
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  234. Rybnik,
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  237. Pyatigorsk, Stavropol Region
  238. Chelyabinsk,
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  240. Krasnodar,
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  272. Taipei City,
  273. Taipei City,
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  281. Bebington, Wirral, Merseyside
  282. Bebington, Wirral, Merseyside
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  284. Northampton, Northamptonshire
  285. Headington, Oxford
  286. Sutton, Surrey
  287. Sutton, Surrey
  288. Glasgow,
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  291. London,
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  5. Kyiv,
  6. Alabaster, Alabama
  7. Bessemer, Alabama
  8. Birmingham, Alabama
  9. Birmingham, Alabama
  10. Birmingham, Alabama
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  12. Birmingham, Alabama
  13. Phoenix, Arizona
  14. Phoenix, Arizona
  15. Scottsdale, Arizona
  16. Tempe, Arizona
  17. Tucson, Arizona
  18. Fayetteville, Arkansas
  19. Rogers, Arkansas
  20. Irvine, California
  21. Newport Beach, California
  22. San Francisco, California
  23. San Francisco, California
  24. San Francisco, California
  25. San Francisco, California
  26. San Francisco, California
  27. San Francisco, California
  28. Santa Barbara, California
  29. New Haven, Connecticut
  30. Miami, Florida
  31. Miami, Florida
  32. Atlanta, Georgia
  33. Atlanta, Georgia
  34. Atlanta, Georgia
  35. Atlanta, Georgia
  36. Atlanta, Georgia
  37. Arlington Heights, Illinois
  38. Baltimore, Maryland
  39. Baltimore, Maryland
  40. Baltimore, Maryland
  41. Newark, New Jersey
  42. Newark, New Jersey
  43. Newark, New Jersey
  44. Newark, New Jersey
  45. Bronx, New York
  46. Bronx, New York
  47. Bronx, New York
  48. Bronx, New York
  49. Mineola, New York
  50. Mineola, New York
  51. Mineola, New York
  52. Mineola, New York
  53. Mineola, New York
  54. Cincinnati, Ohio
  55. Portland, Oregon
  56. Portland, Oregon
  57. Portland, Oregon
  58. Tualatin, Oregon
  59. Dickson, Tennessee
  60. Franklin, Tennessee
  61. Gallatin, Tennessee
  62. Hermitage, Tennessee
  63. Lebanon, Tennessee
  64. Murfreesboro, Tennessee
  65. Nashville, Tennessee
  66. Nashville, Tennessee
  67. Nashville, Tennessee
  68. Nashville, Tennessee
  69. Nashville, Tennessee
  70. Shelbyville, Tennessee
  71. Smyrna, Tennessee
  72. Bedford, Texas
  73. Fort Worth, Texas
  74. Irving, Texas
  75. Irving, Texas
  76. Irving, Texas
  77. San Antonio, Texas
  78. Tyler, Texas
  79. Norfolk, Virginia
  80. Vancouver, Washington
  81. Auchenflower, Queensland
  82. Chermside, Queensland
  83. South Brisbane, Queensland
  84. Southport, Queensland
  85. Brighton, Victoria
  86. East Melbourne, Victoria
  87. Malvern, Victoria
  88. Malvern, Victoria
  89. Malvern, Victoria
  90. Richmond, Victoria
  91. Richmond, Victoria
  92. Charleroi,
  93. Namur,
  94. Split,
  95. Tallinn,
  96. Tallinn,
  97. Tartu,
  98. Budapest,
  99. Budapest,
  100. Debrecen,
  101. Debrecen,
  102. Miskolc,
  103. Cork,
  104. Milano, MI
  105. Roma, RM
  106. Sondrio, SO
  107. Sondrio, SO
  108. Kashiwa, Chiba
  109. Toon, Ehime
  110. Kure, Hiroshima
  111. Sapporo, Hokkaido
  112. Akashi, Hyogo
  113. Kawasaki, Kanagawa
  114. Yokohama, Kanagawa
  115. Hidaka, Saitama
  116. Chuo-ku, Tokyo
  117. Hiroshima,
  118. Niigata,
  119. Gyeonggi-do,
  120. Seoul,
  121. Seoul,
  122. Seoul,
  123. Seoul,
  124. Seoul,
  125. Seoul,
  126. Seoul,
  127. Seoul,
  128. Seoul,
  129. Seoul,
  130. Seoul,
  131. Grudziądz,
  132. Obninsk, Kaluga Region
  133. Sochi, Krasnodarskiy Region
  134. Orenburg, Orenburg Region
  135. Pyatigorsk, Stavropol KRAI
  136. Chelyabinsk,
  137. Ivanovo,
  138. Moscow,
  139. Moscow,
  140. Saint-Petersburg,
  141. Singapore,
  142. Singapore,
  143. Singapore,
  144. Singapore,
  145. Singapore,
  146. Singapore,
  147. Singapore,
  148. Singapore,
  149. Singapore,
  150. Bardejov,
  151. Poprad,
  152. New Taipei city,
  153. New Taipei City,
  154. New Taipei City,
  155. Taipei City,
  156. Taipei,
  157. Taipei,
  158. Taipei,
  159. Taipei,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
Official Title  ICMJE A Phase 2, Multiple-Cohort, Open-Label, International Study of Talazoparib Monotherapy and Talazoparib Plus Temozolomide in Women With Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
Brief Summary The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Talazoparib
    Talazoparib monotherapy 1mg/day orally
    Other Names:
    • MDV3800
    • BMN673
  • Drug: Temozolomide
    temozolomide 37.5 mg/m2 on days 1-5 of each cycle
Study Arms  ICMJE
  • Experimental: talazoparib
    Cohorts 1A (PARP inhibitor naïve), 2A (PARP inhibitor sensitive), and 3A (PARP inhibitor refractory)
    Intervention: Drug: Talazoparib
  • Active Comparator: talazoparib + temozolomide
    Cohorts 1B (PARP inhibitor naïve), 2B (PARP inhibitor sensitive), and 3B (PARP inhibitor refractory)
    Interventions:
    • Drug: Talazoparib
    • Drug: Temozolomide
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2016)
500
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women ? 18 years of age and willing and able to provide informed consent
  • Relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. Histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma.
  • Sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. Consent to blood sample collection for biomarker analysis is required.
  • Disease progression per RECIST 1.1 during or after the last treatment. Have metastatic disease with at least 1 target tumor lesion measurable per RECIST 1.1 on the screening scan. Lesions used for biopsies cannot be designated as a measurable lesion for RECIST 1.1 assessments.
  • Additional criteria for cohort 1 include the following:
  • Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ? 42), which represents a loss of DNA repair function based on testing performed at a sponsor-approved laboratory
  • Received at least 1 and no more than 3 platinum-based chemotherapy regimens (prior bevacizumab is allowed) and the last dose is ? 28 days before randomization
  • No prior PARP inhibitor treatment (COHORT 1 ONLY)
  • Additional criteria for cohorts 2 and 3 include the following:
  • Received at least 2 platinum-based chemotherapy regimens (including first-line chemotherapy; prior bevacizumab is allowed) and the last dose is ? 28 days before randomization
  • Received prior PARP inhibitor treatment as a single agent or in combination therapy regimen and the last dose is ? 28 days before randomization, as follows:
  • For cohort 2 only: Received PARP inhibitor treatment for ? 6 months and had a response of CR, PR, or stable disease for ? 6 months
  • For cohort 3 only: Received PARP inhibitor treatment for < 6 months with no response (disease progression or stable disease)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ? 2.
  • Estimated life expectancy of ? 3 months.
  • Able to swallow drugs, have no known intolerance to study drugs or excipients, and able to comply with study requirements.

Exclusion Criteria:

  • Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ? 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
  • Use of any investigational agent within 14 days before randomization.
  • Had > 2 paracentesis procedures within 28 days before randomization.
  • Major surgery within 14 days before randomization.
  • Requirement for intravenous alimentation (at the time of randomization).
  • Diagnosis of MDS.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836028
Other Study ID Numbers  ICMJE MDV3800-11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Myriad Genetic Laboratories, Inc.
  • Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2018

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