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An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

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Trial Profile

An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 04 Jul 2024

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At a glance

  • Drugs Neratinib (Primary) ; Fulvestrant; Paclitaxel; Trastuzumab
  • Indications Adenocarcinoma; Advanced breast cancer; Biliary cancer; Bladder cancer; Carcinoma; Cervical cancer; Cholangiocarcinoma; CNS cancer; Colon cancer; Colorectal cancer; Endometrial cancer; Gallbladder cancer; Gastric cancer; Glioblastoma; Glioma; Gliosarcoma; HER2 negative breast cancer; HER2 positive breast cancer; Liver cancer; Lung cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Periampullary cancer; Salivary gland cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Uterine cancer
  • Focus Therapeutic Use
  • Acronyms SUMMIT
  • Sponsors Puma Biotechnology

    • Most Recent Events

    • 04 Jun 2024 Results (n=27) assessing safety and efficacy of neratinib alone or in combination with trastuzumab in triple-negative breast cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 12 Mar 2024 Status changed from completed to discontinued.
    • 12 Feb 2024 This protocol has been amended as above-1) Number of treatment arms has been changed from 4 to 6. 2) Primary endpoints has been amended.3) Status of the trial has been changed from completed to terminated.

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