Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of Pf-02341066, A C-met/Hgfr Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer

Trial Profile

Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of Pf-02341066, A C-met/Hgfr Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer

Recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Jun 2018

At a glance

  • Drugs Crizotinib (Primary) ; Itraconazole; Rifampicin
  • Indications Anaplastic large cell lymphoma; Colorectal cancer; Non-small cell lung cancer; Pancreatic cancer; Sarcoma; Solid tumours
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Acronyms PROFILE-1001
  • Sponsors Pfizer
  • Most Recent Events

    • 05 Jun 2018 Results (n=40, data cutoff: 31 Oct 2017) assessing safety and efficacy of crizotinib in patients with low, medium and high levels of MET amplified advanced non-small cell lung cancer, presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 29 May 2018 According to the Pfizer media release, U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for XALKORI (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy, based on the results from an expansion cohort of this study.
    • 29 Jan 2018 Planned End Date changed from 11 Nov 2019 to 1 Jul 2023.
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