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BMN 673

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 15, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

BMN 673 · 2 trials · 5 indications

Phase 1 2
NCT01776437Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male VolunteersHuman Volunteers
COMPLETED18 Analytics
NCT01399840Study of BMN 673, a PARP Inhibitor, in Patients With Advanced Hematological MalignanciesAcute Myeloid Leukemia
COMPLETED33 Analytics
PHASE1COMPLETED
Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
Human VolunteersUnlock trial analytics
PHASE1COMPLETED
Study of BMN 673, a PARP Inhibitor, in Patients With Advanced Hematological Malignancies
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome of this study is to evaluate the effect of food on the relative bioavailability of BMN 673. The Pharmacokinetic analyses of plasma BMN 673 concentration-time will be measured using non-compartmental methods.
4 months
The primary outcome of this study is to determine the MTD of daily oral BMN 673 in patients with AML and MDS (Arm 1) and patients with CLL and MCL (Arm 2).
Assessed after each visit until completion (Estimated duration is 12-18 months)

Secondary Endpoints

Assess the safety and tolerability of BMN 673 during fasting and fed conditions with the following safety assessments: adverse events, physical examination, vital signs, concomitant medications, clinical laboratory tests and ECG.
4 months
Number of participants with adverse events
Assessed after each visit until completion of the study (Estimated duration is 24-30 months)
Determine the pharmacokinetic (PK) profile of BMN 673
Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALPeriod 1: fasted control → Period 2: fed control
Treatment BEXPERIMENTALPeriod 1: fed control → Period 2: fasted control
Arm 1: BMN 673EXPERIMENTALArm 1 will enroll patients with either AML or MDS
Arm 2: BMN 673EXPERIMENTALArm 2 will enroll patients with either CLL or MCL

Interventions

NameTypeDescription
BMN 673DRUG500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male, between the ages of 18 and 55. * Non-smoking for at least 1 year before Screening. * Willing and able to provide informed consent. * Have a BMI between 18 to 30kg/m2. * Willing and able to comply all study procedures. * Have adequate organ function * Sexually active pati...

Countries:United StatesUnited Kingdom
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Frequently asked questions about BMN 673

What is BMN 673 used for?

BMN 673 is a small molecule being studied for use in Acute Myeloid Leukemia and other advanced hematological malignancies, as well as in healthy human volunteers. It is an investigational drug in Phase 1 clinical development and is not yet approved for any indication.

Who makes BMN 673?

BMN 673 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain blood cancers and in healthy volunteers.

What phase is BMN 673 in?

BMN 673 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in patients with advanced hematological malignancies and one in healthy adult male volunteers. The drug remains investigational and has not received FDA approval.

What clinical trials is BMN 673 in?

BMN 673 has been studied in two completed Phase 1 trials. NCT01399840 enrolled 33 patients with Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, and Mantle Cell Lymphoma. NCT01776437 enrolled 18 healthy adult male volunteers. Both trials were conducted in the United States, with the first also in the United Kingdom.

Is BMN 673 the same as talazoparib?

BMN 673 is also known as talazoparib, a PARP inhibitor. In clinical trials, it has been evaluated for its effects in patients with advanced hematological malignancies and in healthy volunteers. The drug is being developed by Pfizer, Inc.