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Trial · NCT02874664

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.12 weeks
SecondaryChange in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.12 weeks
SecondaryChange in PR interval from baseline PR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.12 weeks
SecondaryChange in QRS duration interval from baseline QRS duration following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.12 weeks
Secondary
Change in waveform composition interval from baseline waveform composition following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
12 weeks
SecondaryRelationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.12 weeks
SecondaryIncidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.12 weeks
SecondaryIncidence of adverse events.From first dose through 30 days post-last-dose
SecondaryObjective response rateBaseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
SecondaryDuration of responseBaseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
SecondaryProgression free survivalBaseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
SecondaryOverall survivalBaseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
SecondaryClinical benefit ratioBaseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
SecondaryMaximum Plasma Concentration (Cmax)Cycles 1 and 2: Day 1 (predose, 30 min, 2 and 4 hours postdose) and days 2,3,4,8,15,and 29; Cycles 4,5,7,8: Day 1 predose and 30 min postdose.
SecondaryArea Under the Curve (AUC)Cycles 1 and 2: Day 1 (predose, 30 min, 2 and 4 hours postdose) and days 2,3,4,8,15,and 29; Cycles 4,5,7,8: Day 1 predose and 30 min postdose.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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