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Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

StatusTerminated
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v10

  2. Notable

    Reclassified as terminated (was completed)

    Sponsor's reason: Sponsor stopped enrollment at 50 of 70 planned patients because an activity signal had been observed in lymphoma and further enrollment would not add significantly to interpretation of efficacy or safety.

    Primary and study completion dates: Apr 2012 to Jun 30, 2009; Start date: Dec 2006 to Dec 29, 2006

    Study Statusv9

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  4. Notable

    Primary and study completion dates changed from estimate of Jun 2009 to Apr 2012

    Trial status: Active, Not Recruiting to Completed; Enrollment target: estimated 70 to confirmed 50

    Study Status, Sponsor/Collaborators, Study Designv7

  5. Minor

    Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v6

Show 4 earlier versions

  1. 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: Chicago, country: United States, geoPoint: {'lat': 41.85003, 'lon': -87.65005}, state: Illinois, status: RECRUITING city: Bethesda, country: United States, geoPoint: {'lat': 38.98067, 'lon': -77.10026}, state: Maryland, status: RECRUITING city: Fargo, country: United States, geoPoint: {'lat': 46.87719, 'lon': -96.7898}, state: North Dakota, status: RECRUITING city: Sioux Falls, country: United States, geoPoint: {'lat': 43.54369, 'lon': -96.72796}, state: South Dakota, st [...] [...]

    Study Status, Contacts/Locationsv5

  2. Minor

    Study sites revised (6)

    Show what changed: Study sites
    city: Sioux Falls, country: United States, geoPoint: {'lat': 43.54369, 'lon': -96.72796}, state: South Dakota, status: NOT_YET_RECRUITINGRECRUITING

    Study Status, Contacts/Locationsv4

  3. Notable

    Enrollment target: 40 to 70

    Primary and study completion dates: Aug 2008 to Jun 2009; Study sites: 11 to 6; Eligibility criteria shortened, about 7 words

    Show what changed: Eligibility criteria
    Inclusion Criteria BloodHodgkin's or bonenon-Hodgkin's marrow cancers including lymphoma, MDS, AML and APLLymphoma. ≥ 1 prior therapy and currently requiring therapy. Evaluab [...]

    Study Status, Sponsor/Collaborators, Conditions, Study Design, Eligibility, Contacts/Locationsv3

  4. Minor

    Study sites: 4 to 11

    Primary and study completion dates: Aug 2008; Start date: Dec 2006; Interventions: ZIO-101 (Drug) to Darinaparsin (Drug); and 2 more

    Show all 6 changes in this update
    • Minor Study sites: 4 to 11
    • Minor Primary and study completion dates: Aug 2008
    • Minor Start date: Dec 2006
    • Minor Interventions: ZIO-101 (Drug) to Darinaparsin (Drug)
    • Minor Eligibility criteria expanded, about 211 words
      Show what changed
      Inclusion Criteria: SubjectsBlood or bone marrow cancers including lymphoma, MDS, AML and APL. ≥ 1 prior therapy and currently requiring therapy. Evaluable disease (defined by disease-specific criteria listed in Appendix 1) ≥ 18 years of age. ECOG performance score ≤ 2 (see Appendix 2). Life-expectancy ≥ 2 months. Written info [...] with hematologicalZIOPHARM malignanciespolicies whoand havethe receivedHuman atInvestigation leastReview twoCommittee priorwith therapiesjurisdiction over the site. No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1). The following [...]
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, 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 hematological malignancies.
Trial Details
NCT Number NCT00421213
Lead Sponsor Alaunos Therapeutics
Conditions Hematologic Neoplasms, Bone Marrow Neoplasms, Non-Hodgkin's Lymphoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov