Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer

Titre officiel

A Phase II Study of Talazoparib (BMN 673) in Patients With Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

Sommaire:

Cet essai de phase II vise à évaluer l’efficacité du talazoparib chez des patients atteints d’un cancer du poumon à cellules squameuses de stade IV associé à un déficit de réparation de l’ADN par recombinaison homologue qui a récidivé après un traitement antérieur. Le talazoparib pourrait stopper la croissance des cellules tumorales en bloquant certaines enzymes nécessaires à la croissance cellulaire.

Description de l'essai

Primary Outcome:

  • Overall response rate assessed by Response Evaluation Criteria in Solid Tumours 1.1 (Design #2)
Secondary Outcome:
  • Duration of response (Design #2)
  • Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Design #2)
  • Median investigator assessed progression-free survival (IA-PFS) (Design #2)
  • Overall survival (OS) (Design #2)
PRIMARY OBJECTIVES:
  • To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients.
SECONDARY OBJECTIVES:
  • To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with therapy in HRRD MDVN-positive patients.
  • To evaluate ORR, IA-PFS, and OS in HRRD Foundation Medicine, Inc. (FMI)-positive patients.
  • To evaluate ORR in HRRD MDVN-negative/HRRD FMI-positive patients.
  • To evaluate the frequency and severity of toxicities associated with talazoparib (BMN 673) in HRRD FMI-positive patients.
TERTIARY OBJECTIVES:
  • To assess if the homologous recombination deficiency (HRD) score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib (BMN 673).
  • To assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib (BMN 673).
  • To characterize pharmacokinetic properties of talazoparib (BMN 673).
OUTLINE:
Patients receive talazoparib orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and at the end of year 3.

Voir cet essai sur ClinicalTrials.gov

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