Author of

• 35481

  +

  P29 - Palliative and Supportive Care - Clinical Trial in Progress (ID 162)

  • Event: WCLC 2020
  • Type: Posters
  • Track: Palliative and Supportive Care
  • Presentations: 1
  • Moderators:
  • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall

  • 35483

    +

    P29.02 - TIP: Romiplostim for Chemo-Induced Thrombocytopenia in Adults with Solid Tumors; A P3 Randomized Placebo-Controlled Double-Blind Studies (ID 1952)

    00:00 - 00:00  |  Presenting Author(s): Armando Armas
    • Abstract
    • Presentation

    Introduction
    

    Data was also submitted for consideration at ASCO 2020

    Methods
    

    Current treatment for Chemotherapy induced thrombocytopenia includes platelet transfusion and chemotherapy dose delays, dose omissions, dose reduction. Transfusions are typically reserved for severe cases and dose delays and reductions can have a negative impact on the long-term outcomes of chemotherapy relative dose intensity. Phase 1/2 studies in solid tumors using pre and post chemotherapy schemas demonstrated the safety and efficacy of romiplostim in these settings.

    Results
    

    Two phase 3 randomized placebo controlled double blind studies of romiplostim for the treatment of CIT are currently ongoing. In each trial, 162 patients will be randomized by tumor type and baseline platelet count in a 2-1 ratio receiving Romiplostim or placebo. Romiplostim starting dose is 2 μg/kg SC weekly.

    The clinical trial (NCT:03362177 and NCT: 03937154) are enrolling patients receiving 5-fluorouracil and oxaliplatin (FOLFOX) based chemotherapy regimens for treatment of GI or colorectal cancer and patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer respectively.

    Conclusion
    

    The primary endpoint for both studies is incidence of thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Secondary endpoints include depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of treatment period, time to first platelet response, duration adjusted event rate of grade 2 or higher bleeding events, overall survival, and incidence of platelet transfusions. More details about the studies will be included in the poster presentation

    Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.