Source: https://kumc.trialstoday.org/trial/NCT03678883
Timestamp: 2020-07-09 12:09:35
Document Index: 716615794

Matched Legal Cases: ['art 1', 'art 2', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 3', 'art 3']

9-ING-41 Drug: 9-ING-41
9-ING-41 plus Gemcitabine Drugs: Gemcitabine - 21 day cycle. 9-ING-41
9-ING-41 plus Doxorubicin Drugs: Doxorubicin. 9-ING-41
9-ING-41 plus Lomustine Drugs: Lomustine. 9-ING-41.
9-ING-41 plus Carboplatin Drugs: Carboplatin. 9-ING-41.
9-ING-41 plus nab paclitaxel Gemcitabine Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.
9-ING-41 plus Paclitaxel/Carboplatin Drugs: Paclitaxel. Carboplatin. 9-ING-41.
9-ING-41 plus Irinotecan Drugs: Irinotecan. 9-ING-41.
fgiles@actuatetherapeutics.com
- Part 1 (9-ING-41 as monotherapy): The standard 3+3 dose escalation design will be applied to all dose cohorts until the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) is identified
- Part 2: 9-ING-41 combined with standard anticancer agents: The 3+3 dose escalation study design will be used for 7 chemotherapy combination regimens (9-ING-41 plus gemcitabine, doxorubicin, lomustine, carboplatin, irinotecan, nab-paclitaxel plus gemcitabine, paclitaxel plus carboplatin) to identify the MTD/RP2D of each regimen. Part 2 will be started after a maximum of 3 dose escalations of 9-ING-41 as a single agent in Part 1. The starting dose level in Part 2 of 9-ING-41 within the seven combination regimens will be the 4th dose level of single agent 9-ING-41 (or lower if the IDMC so recommends). Dose escalations of 9-ING-41 as a single agent in Part 1 will continue in parallel with dose escalations of 9-ING-41 in combination treatments in Part 2.
- Part 3: Assessment of activity of 9-ING-41 based combination regimens: The primary objective for Study Part 3 is to assess the clinical benefit of each of the seven 9-ING-41-based combination regimens. Secondary objectives will include the assessment of other efficacy variables, including progression-free survival (PFS), duration of tumor response, time to treatment failure, 1-year survival rate and overall survival (OS) as well as additional evaluation of toxicities. The Simon's 2-stage design will be employed for Study Part 3 for the seven 9-ING-41-based combination regimens.
This study (NCT03678883) was last processed and updated on 5/27/2020 by ClinicalTrials.gov.