Status:
COMPLETED
Study of BMN 673, a PARP Inhibitor, in Patients With Advanced Hematological Malignancies
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a two-arm, open-label study to determine the maximum tolerated dose (MTD) and assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BMN 673 in patients with Acute ...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Arm 1 AML/MDS: Must have available tissue
- Arm 2 CLL/MCL: Must have available tissue
- Have adequate organ function as defined below:
- Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN);
- Total serum bilirubin ≤ 1.5 X ULN;
- Able to take oral medications
- Recovered from acute toxicity of prior treatment
- 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.
- 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.
- 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.
- Willing and able to comply with all study procedures.
Exclusion
- Acute promyelocytic leukemia, APL \[AML with t(15;17)(q22;q12), PML-RARA and variants\].
- Disease-specific 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
- Autologous bone marrow transplant \< 6 months before Cycle 1 Day 1
- Prior allogeneic bone marrow transplant \< 6 months before Cycle 1 Day 1 and/or with the presence of graft versus host disease (GVHD)
- Prior treatment:
- AML: anti-leukemia treatment within 14 days before Cycle 1 Day 1; hydroxyurea treatment within 7 days before Cycle 1 Day 1.
- CLL, MCL or MDS: anti-lymphoma/leukemia treatment within 28 days before Cycle 1 Day 1;
- CLL/MCL patients who have received transfusion, hematopoietic growth factors within 7 days before Cycle 1 Day 1.
- Symptomatic central nervous system (CNS) involvement.
- Known to have human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV).
- Major surgery within 28 days before Cycle 1, Day 1.
- Active peptic ulcer disease.
- Active gastrointestinal tract disease with malabsorption syndrome.
- Requirement for IV alimentation.
- Prior surgical procedures affecting absorption.
- Uncontrolled inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- 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.
- Breastfeeding at screening or planning to become pregnant (self or partner) at any time during study participation.
- Use of any investigational product or investigational medical device within 28 days before Cycle 1, Day 1.
- Concurrent disease or condition that would interfere with study participation or safety, such as:
- 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);
- Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders;
- Non-healing wound, ulcer, or bone fracture.
- 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.
Key Trial Info
Start Date :
June 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01399840
Start Date
June 30 2011
End Date
May 31 2014
Last Update
September 15 2017
Active Locations (7)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
3
University of Wisconsin
Madison, Wisconsin, United States, 53715
4
University College London
London, United Kingdom, NW1 2BU