Study of BMN 673, a PARP Inhibitor, in Patients With Advanced Hematological Malignancies
NCT ID: NCT01399840
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2011-06-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: BMN 673
Arm 1 will enroll patients with either AML or MDS
BMN 673
Oral capsule with multiple dosage forms given once daily
Arm 2: BMN 673
Arm 2 will enroll patients with either CLL or MCL
BMN 673
Oral capsule with multiple dosage forms given once daily
Interventions
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BMN 673
Oral capsule with multiple dosage forms given once daily
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
3. Arm 1 AML/MDS: Must have available tissue
4. Arm 2 CLL/MCL: Must have available tissue
5. Have adequate organ function as defined below:
1. Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN);
2. Total serum bilirubin ≤ 1.5 X ULN;
6. Able to take oral medications
7. Recovered from acute toxicity of prior treatment
8. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
9. If sexually active, must be willing to use an acceptable method of contraception during therapy and for 30 days after the last dose of BMN 673.
10. If female of childbearing potential, must have a negative serum pregnancy test at screening and be willing to have additional pregnancy tests during the study.
11. Willing and able to comply with all study procedures.
Exclusion Criteria
a. AML: i. Marrow cellularity \< 25% ii. Circulating blasts \> 50,000/mm3 b. MCL and CLL: i. Platelet count \< 50,000/mm3 ii. Neutrophil count \< 1000/mm3
3. Autologous bone marrow transplant \< 6 months before Cycle 1 Day 1
4. Prior allogeneic bone marrow transplant \< 6 months before Cycle 1 Day 1 and/or with the presence of graft versus host disease (GVHD)
5. Prior treatment:
1. AML: anti-leukemia treatment within 14 days before Cycle 1 Day 1; hydroxyurea treatment within 7 days before Cycle 1 Day 1.
2. CLL, MCL or MDS: anti-lymphoma/leukemia treatment within 28 days before Cycle 1 Day 1;
6. CLL/MCL patients who have received transfusion, hematopoietic growth factors within 7 days before Cycle 1 Day 1.
7. Symptomatic central nervous system (CNS) involvement.
8. Known to have human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV).
9. Major surgery within 28 days before Cycle 1, Day 1.
10. Active peptic ulcer disease.
11. Active gastrointestinal tract disease with malabsorption syndrome.
12. Requirement for IV alimentation.
13. Prior surgical procedures affecting absorption.
14. Uncontrolled inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
15. Myocardial infarction within 6 months before Cycle 1 Day 1, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
16. Breastfeeding at screening or planning to become pregnant (self or partner) at any time during study participation.
17. Use of any investigational product or investigational medical device within 28 days before Cycle 1, Day 1.
18. Concurrent disease or condition that would interfere with study participation or safety, such as:
1. CLL/MCL patients with active, clinically significant infection requiring the use of parenteral anti-microbial agents, or grade \> 2 infection by NCI CTCAE (v4.03) within 14 days before Cycle 1, Day 1(AML/MDS patients with controlled infection are eligible for the study with no specific time requirement prior to Cycle 1, Day 1);
2. Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders;
3. Non-healing wound, ulcer, or bone fracture.
19. Patients who have received prior treatment with a PARP inhibitor are not eligible for Part 2 of the study (expansion), but are eligible for Part 1 (dose escalation) of the study.
18 Years
ALL
No
Sponsors
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Medivation, Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
University College London
London, , United Kingdom
King's College Hospital
London, , United Kingdom
The Christie NHS Foundation
Manchester, , United Kingdom
University of Newcastle Upon Tyne, NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Gopal AK, Popat R, Mattison RJ, Menne T, Bloor A, Gaymes T, Khwaja A, Juckett M, Chen Y, Cotter MJ, Mufti GJ. A Phase I trial of talazoparib in patients with advanced hematologic malignancies. Int J Hematol Oncol. 2021 Oct 22;10(3):IJH35. doi: 10.2217/ijh-2021-0004. eCollection 2021 Sep.
Other Identifiers
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2010-023964-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3441022
Identifier Type: OTHER
Identifier Source: secondary_id
PRP-002
Identifier Type: -
Identifier Source: org_study_id