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Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Nov 2024 to Nov 2027
    • Study completion date: Nov 2025 to Nov 2027
    v4
  2. 2 versions Re-verified since Apr 16, 2023, no change to tracked fieldsv2-v3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single arm, open-label, phase I dose finding study, followed by a phase II expansion study. Phase I will be carried out in a modified 3+3 dose escalation design, with a projected enrolment of 33 patients with refractory solid tumors to determine the RP2D. In the phase II portion, a total of 30 patients with advanced/metastatic TNBC will be enrolled.
Trial Details
NCT Number NCT05035745
Lead Sponsor National University Hospital, Singapore
Conditions
(from sponsor)		 Advanced Refractory Solid Tumors, Advanced Triple Negative Breast Cancers, Metastatic Triple Negative Breast Cancers
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov