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Acute Myeloid LeukemiaPhase 1NCT01399840

Study of BMN 673, a PARP Inhibitor, in Patients With Advanced Hematological Malignancies

A Phase 1 study testing BMN 673 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Pfizer at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMN 673
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
7 sitesin 2 countries
Study dates
30 Jun 2011to 31 May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • Acute promyelocytic leukemia, APL [AML with t(15;17)(q22;q12), PML-RARA and variants].
  • Disease-specific exclusion criteria:
  • 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:
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  • 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.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United Kingdom4 sites

  • University College London

    London, NW1 2BU

  • King's College Hospital

    London, SE5 9RS

  • The Christie NHS Foundation

    Manchester, M20 4BX

  • University of Newcastle Upon Tyne, NHS Foundation Trust

    Newcastle upon Tyne, NE1 7RU

Other trials in United Kingdom

United States3 sites

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Wisconsin

    Madison, Wisconsin, 53715

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

Other trials in United States

About this study

Official title: Phase 1, Two-arm, Open-label Study Of Once Daily, Oral Bmn 673 In Patients With Advanced Hematological Malignancies

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 Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). Arm 1 will enroll patients with either AML or MDS; Arm 2 will enroll patients with either CLL or MCL.

Being tested
BMN 673
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMN 673Drug

    Oral capsule with multiple dosage forms given once daily

Study groups in NCT01399840
Study groupRoleWhat they receive
Arm 1: BMN 673ExperimentalArm 1 will enroll patients with either AML or MDS
Receives: Drug: BMN 673
Arm 2: BMN 673ExperimentalArm 2 will enroll patients with either CLL or MCL
Receives: Drug: BMN 673

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Assessed after each visit until completion (Estimated duration is 12-18 months)

Secondary outcomes (4)

  1. Number of participants with adverse events

    Measured: Assessed after each visit until completion of the study (Estimated duration is 24-30 months)

  2. Determine the pharmacokinetic (PK) profile of BMN 673

    Sample collection times vary per visit. PK parameters that will be evaluated include: maximum concentration (Cmax), minimum concentration (Cmin), time to maximum plasma concentration (Tmax), area under the curve from 0 to last quantifiable sampling point postdose (AUC0-inf), area under the curve extrapolated to infinity (AUC0-last), half life (t1/2), systemic clearance (CL/f) and volume of ditribution (VZ/f)

    Measured: Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months)

  3. Determine the Recommended Phase 2 Dose (RP2D) of oral daily BMN 673

    Measured: Assessed after each visit until completion of the study (Estimated duration is 24-30 months)

  4. Assess preliminary efficacy of BMN 673 by evaluating per response publications

    Measured: Assessed approximately every 4-12 weeks (Estimated duration is 24-30 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2011 (estimated)
  2. Study start30 Jun 2011
  3. Primary completion31 Mar 2014
  4. Study completion31 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01399840
Sponsor's protocol ID
PRP-002
Other IDs
2010-023964-42, C3441022
Status last verified
Sep 2017
First submitted
13 Jul 2011
Last updated
15 Sep 2017
Results posted
No
Individual data sharing
No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Publications

  • 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.

    PubMed 34840720

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMN 673 in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Pfizer at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Assessed after each visit until completion (Estimated duration is 12-18 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01399840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.

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