A Study of PTX-9908 Injection for Non-resectable HCC With TACE

StatusWithdrawn
PhasePhase 1/2
Started

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Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: Due to business considerations and challenges in participant recruitment, the Sponsor has decided to discontinue the study. Show 6 more changesShow less
    • Enrollment target: estimated 50 to confirmed 0
    • Study completion moved earlier from Dec 30, 2026 to Aug 14, 2026
    • Primary completion date changed from estimate of Aug 30, 2026 to Aug 14, 2026
    • Secondary endpoints: details revised at 6 of 7 entries
    • Site details revised
    • Eligibility criteria expanded, about 3 words
  2. Primary completion date: Aug 30, 2024 to Aug 30, 2026
    • Study completion date: Dec 30, 2024 to Dec 30, 2026
    • Site details revised
    v6
  3. Primary completion date: Aug 30, 2023 to Aug 30, 2024
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    v5
  4. Primary completion date: Aug 30, 2021 to Aug 30, 2023
    • Study completion date: Dec 30, 2021 to Dec 30, 2023
    v4
  5. Start date: Feb 4, 2020 to Oct 6, 2020v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Aug 1, 2019 to Feb 4, 2020
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints: 8 to 7
    • Site details revised
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, Phase I/II study in patients with non-resectable hepatocellular carcinoma following TACE treatment. Phase I (Open-label dose escalation) This study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg/kg, and 2 mg/kg) is planned. For the dose levels in the standard phase (4 mg/kg, 8 mg/kg and 16 mg/kg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period. Phase II (Randomized placebo controlled dose expansion) The objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.
Trial Details
NCT Number NCT03812874
Lead Sponsor TCM Biotech International Corp.
Conditions
(from sponsor)		 Carcinoma, Hepatocellular
Related terms Carcinoma, Hepatocellular
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov