Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PLX8394 in Patients With Advanced Unresectable Solid Tumors

Trial Profile

Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PLX8394 in Patients With Advanced Unresectable Solid Tumors

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 30 Oct 2017

At a glance

  • Drugs PLX 8394 (Primary) ; Cobicistat
  • Indications Malignant melanoma; Solid tumours
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Plexxikon
  • Most Recent Events

    • 25 Oct 2017 According to the results of phase I presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2017, the study protocol was amended and 11 additional patients (8 with BRAF mutation) were enrolled in cohorts with PLX8394 coadministered with cobicistat: 450mg BID (n=5) and 900mg BID (n=6) as the PK studies demonstrated lower than expected drug exposures.
    • 25 Oct 2017 Results of phase I presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2017.
    • 19 Sep 2017 Planned End Date changed from 1 May 2018 to 1 Apr 2018.
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