Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00423306 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma

StatusTerminated
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, Conditions, Study Design

    Re-verified, no change to tracked fields

    v12

  2. Notable

    Reclassified as terminated (was completed)

    Sponsor's reason: Study closed after Stage 1 (15 of 40 planned patients treated) due to lack of treatment response; criteria to proceed to Stage 2 were not met.

    Primary and study completion dates: Aug 8, 2008 to Aug 9, 2008; Start date: May 7, 2007 to May 1, 2007

    Study Statusv11

  3. Notable

    Start date: Jan 2007 to May 7, 2007

    Trial status: Active, Not Recruiting to Completed; Primary and study completion dates changed from estimate of Dec 2013 to Aug 8, 2008

    Study Statusv10

  4. Minor

    Primary and study completion dates: Jun 2013 to Dec 2013

    Study Statusv9

  5. Notable

    Primary and study completion dates: Sep 2008 to Jun 2013

    Trial status: Completed to Active, Not Recruiting

    Study Status, Sponsor/Collaborators, Conditionsv8

Show 6 earlier versions

  1. Minor

    Enrollment target: estimated 60 to confirmed 15

    Study Status, Sponsor/Collaborators, Study Designv7

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary and study completion dates changed from estimate of Dec 2008 to Sep 2008

    Study Statusv6

  3. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Study sites revised (6)

    Show what changed: Study sites
    city: Miami, country: United States, geoPoint: {'lat': 25.77427, 'lon': -80.19366}, state: Florida, status: RECRUITING city: Atlanta, country: United States, geoPoint: {'lat': 33.749, 'lon': -84.38798}, state: Georgia, status: RECRUITING city: Boston, country: United States, geoPoint: {'lat': 42.35843, 'lon': -71.05977}, state: Massachusetts, status: RECRUITING city: Kansas City, country: United States, geoPoint: {'lat': 39.09973, 'lon': -94.57857}, state: Missouri, status: RECRUITING city: New York, country: United States, geoPoint: {'lat': 40.71427, 'lon': -74.00597}, state: New York, status [...] [...]

    Study Status, Sponsor/Collaborators, Contacts/Locationsv5

  4. Minor

    Study sites: 5 to 6

    Primary and study completion dates: Dec 2008; Start date: Jan 2007; Interventions: ZIO-101 (Drug) to Darinaparsin (Drug); and 2 more

    Show all 6 changes in this update
    • Minor Study sites: 5 to 6
    • Minor Primary and study completion dates: Dec 2008
    • Minor Start date: Jan 2007
    • Minor Interventions: ZIO-101 (Drug) to Darinaparsin (Drug)
    • Minor Eligibility criteria expanded, about 551 words
      Show what changed
      Inclusion Criteria: SubjectsHCC withdiagnosed hepatocellularby carcinomahistology or clinical evidence supported by liver mass(es) at least 2cm in the longest diameter and AFP equal to or more than 500 ng/mL in cirrhosis or chronic HBV or HCV infection27. Male or female patients ≥ 18 years of age Patients who have a life expectancy of at least 12 weeks Patients who have [...] who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion whic [...] [...]
    • Minor Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv4

  5. Minor

    Study sites revised (5)

    Show what changed: Study sites
    city: Miami, country: United States, geoPoint: {'lat': 25.77427, 'lon': -80.19366}, state: Florida, status: NOT_YET_RECRUITINGRECRUITING city: Seattle, country: United States, geoPoint: {'lat': 47.60621, 'lon': -122.33207}, state: Washington, status: NOT_YET_RECRUITINGRECRUITING

    Study Status, Contacts/Locationsv3

  6. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Study sites: 3 to 5

    Study Status, Contacts/Locationsv2

  1. Minor

    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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study of safety of a new organic arsenic compound in the treatment of advanced hepatocellular carcinoma
Trial Details
NCT Number NCT00423306
Lead Sponsor Alaunos Therapeutics
Conditions Hepatocellular Carcinoma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov