5295W-12: Daiichi NSCLC

CRC 12058: A Phase 1, Open-Label, Multiple-Ascending-Dose Study of DS-2248, an Orally Bioavailable Heat Shock Protein 90 Inhibitor, in Subjects With Advanced Solid Tumors

Type of Study
Cancer (Oncology) - Lung
Location
Swedish Cancer Institute
Short Description

Purpose: This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors. The patients who qualify for the study will receive a once daily dose of the drug taken by mouth and will undergo several tests to measure the drug in the blood and to understand the safety, tolerability and any effect of the drug on the tumor. The antitumor effect of the drug is not known in human.

Status
Open to Enrollment
Principal Investigator
Howard (Jack) West, M.D.
Eligibility Notes
  • Pathologically documented stage IIIB/IV non-small cell lung cancer
  • Acquired resistance to reversible Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI), which should meet the following criteria:
    • Previous treatment with single-agent therapy (erlotinib, gefitinib, afatinib).
    • Either of the following: A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) -OR- Prior objective clinical benefit from EGFR-TKI, as evidenced by complete response (CR), partial response (PR), or stable disease (SD) ≥6 months as defined by RECIST or World Health Organization criteria.
    • Systemic progression of disease as defined by RECIST or WHO criteria while treatment with gefitinib, erlotinib, or afatinib.
    • No intervening therapy other than EGFR-TKIs (erlotinib, gefitinib, afatinib) after progression on an EGFR-TKI.
    • Pre-treatment biopsy (performed via bronchoscopy or imaging guidance) for molecular testing of the tumor is desired but not mandatory for enrollment in Stage 1. However, pre-treatment biopsy within 21 days prior to the first day of treatment is required for enrollment in Stage 2.
  • Presence of ALK fusion gene in the tumor demonstrated by FISH and the subject has acquired resistance to ALK inhibitor therapy.
  • No gastrointestinal diseases that could affect the absorption of DS-2248.
  • No subjects with peptic ulcer disease requiring on-going treatment with pH-modifiers
  • No subjects with history of inflammatory bowel disease.
  • No subjects with retinal or uveal diseases including macular degeneration with central vision loss, retinal detachment, diabetic retinopathy, and uveitis.
  • No recipient of a stem cell or bone marrow transplant
  • No prior treatment with Hsp90 inhibitors
  • No intervening therapy after progression on an EGFR-TKI (erlotinib, gefitinib, afatinib), unless re-treated with EGFR-TKI.
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org