NCT01399840

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2011

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2014

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

July 13, 2011

Last Update Submit

September 14, 2017

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Lymphocytic LeukemiaMantle Cell Lymphoma

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (4)

  • 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)

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

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

  • Assess preliminary efficacy of BMN 673 by evaluating per response publications

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

Study Arms (2)

Arm 1: BMN 673

EXPERIMENTAL

Arm 1 will enroll patients with either AML or MDS

Drug: BMN 673

Arm 2: BMN 673

EXPERIMENTAL

Arm 2 will enroll patients with either CLL or MCL

Drug: BMN 673

Interventions

BMN 673DRUG

Oral capsule with multiple dosage forms given once daily

Arm 1: BMN 673Arm 2: BMN 673

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute promyelocytic leukemia, APL \[AML with t(15;17)(q22;q12), PML-RARA and variants\].
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

University College London

London, NW1 2BU, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

The Christie NHS Foundation

Manchester, M20 4BX, United Kingdom

Location

University of Newcastle Upon Tyne, NHS Foundation Trust

Newcastle upon Tyne, NE1 7RU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34840720DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-Cell

Interventions

talazoparib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphoma

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 22, 2011

Study Start

June 30, 2011

Primary Completion

March 31, 2014

Study Completion

May 31, 2014

Last Updated

September 15, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

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

Locations

US(3)GB(4)