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IDHIRANCT06607302

Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
Track this trial

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 16 → 19 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 6 of 25 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 13 → 16 locationsv6
  3. Study sites: 7 to 13v5
  4. Study sites: 2 to 7v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 31, 2024 to Oct 8, 2024
    v3
  6. Start date: Sep 30, 2024 to Oct 31, 2024
    • Secondary endpoints: details revised at 2 of 25 entries
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression-free survival (PFS)
Timeframe: max. 38 months (FPI - LPLV)

Secondary (25)

Overall survival (OS)
Timt to treatment failure (TTF)
Overall response rate (ORR)
Disease control rate (DCR)
(Serious) adverse events ((S)AE))
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(Serious) adverse drug reactions ((S)ADR) related to ivosidenib
Adverse events of special interest (AESI)
Global health-related quality of life during course of treatment
Cholangiocarcinoma-related quality of life during course of treatment
Assessing parameters of physician treatment decision making
Assessing parameters of physician treatment satisfaction
Cumulative ivosidenib dose
Absolute dose intensity of ivosidenib
Relative dose intensity of ivosidenib
Frequency of dose modifications
Type of dose modifications
Reasons for dose modifications
Duration of treatment with ivosidenib
Reasons for end of treatment (EOT)
Type of last previous therapy
Frequency of last previous therapy
Duration of last previous therapy line
Concomitant medications
Concomitant medications known to induce QT prolongation
Subsequent antineoplastic therapies

Sites

19 sites in 1 country