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NCT01399840

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

Completed Phase 1 Last updated 15 September 2017
What this trial tests

Phase 1 trial testing BMN 673 in Acute Myeloid Leukemia in 33 participants. Completed in 31 May 2014.

Timeline
30 June 2011
Primary endpoint
31 March 2014
31 May 2014

Quick facts

Lead sponsorPfizer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date30 June 2011
Primary completion31 March 2014
Estimated completion31 May 2014
Sites7 locations across United Kingdom, United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting DNA damage response in cancer therapy.
    Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
  2. Targeting DNA repair pathways for cancer treatment: what's new?
    Kelley MR, Logsdon D, Fishel ML. · · 2014 · cited 143× · PMID 24947262 · DOI 10.2217/fon.14.60
  3. Role of PARP inhibitors in cancer biology and therapy.
    Davar D, Beumer JH, Hamieh L, Tawbi H. · · 2012 · cited 90× · PMID 22788767 · DOI 10.2174/092986712802002464
  4. Targeting PARP proteins in acute leukemia: DNA damage response inhibition and therapeutic strategies.
    Padella A, Ghelli Luserna Di Rorà A, Marconi G, Ghetti M, et al · · 2022 · cited 73× · PMID 35065680 · DOI 10.1186/s13045-022-01228-0
  5. Microsatellite instability induced mutations in DNA repair genes CtIP and MRE11 confer hypersensitivity to poly (ADP-ribose) polymerase inhibitors in myeloid malignancies.
    Gaymes TJ, Mohamedali AM, Patterson M, Matto N, et al · · 2013 · cited 54× · PMID 23349304 · DOI 10.3324/haematol.2012.079251
  6. PARP Inhibitors and Myeloid Neoplasms: A Double-Edged Sword.
    Csizmar CM, Saliba AN, Swisher EM, Kaufmann SH. · · 2021 · cited 33× · PMID 34945003 · DOI 10.3390/cancers13246385
  7. PARP1 expression, activity and ex vivo sensitivity to the PARP inhibitor, talazoparib (BMN 673), in chronic lymphocytic leukaemia.
    Herriott A, Tudhope SJ, Junge G, Rodrigues N, et al · · 2015 · cited 27× · PMID 26539646 · DOI 10.18632/oncotarget.6287
  8. Involvement of classic and alternative non-homologous end joining pathways in hematologic malignancies: targeting strategies for treatment.
    Valikhani M, Rahimian E, Ahmadi SE, Chegeni R, et al · · 2021 · cited 20× · PMID 34732266 · DOI 10.1186/s40164-021-00242-1

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Other trials of BMN 673

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01399840.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing