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Trial · NCT03441555

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryTmax of venetoclaxApproximately 32 days after first dose of study drugTime to maximum plasma concentration (Tmax) of venetoclax
PrimaryClearance of AlvocidibApproximately 32 days after first dose of study drugClearance (CL) of alvocidib
PrimaryAUC0-∞ of AlvocidibApproximately 32 days after first dose of study drugArea under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of alvocidib
PrimaryCmax of VenetoclaxApproximately 32 days after first dose of study drugMaximum plasma concentration (Cmax) of venetoclax
PrimaryHalf-life (t1/2) of AlvocidibApproximately 32 days after first dose of study drugHalf-life (t1/2) of alvocidib
PrimaryAUC0-24 Post-dose of VenetoclaxApproximately 32 days after first dose of study drugArea under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
PrimaryCmax of AlvocidibApproximately 32 days after first dose of study drugMaximum plasma concentration (Cmax) of alvocidib.
PrimaryAUCt Post-dose of AlvocidibApproximately 32 days after first dose of study drugArea under the plasma concentration-time curve from time zero to time t (AUCt) post-dose alvocidib.
PrimaryDose Escalation Phase: Recommended Phase 2 dose (RPTD) for Venetoclax and AlvocidibMinimum first cycle of dosing (up to 28 days)RPTD will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.
SecondaryComplete Response (CR) RateUp to approximately 8 monthsCR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
SecondaryCombined CR RateUp to approximately 8 monthsCombined CR rate is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
SecondaryObjective Response Rate (ORR)Up to approximately 18 monthsORR is defined as the proportion of participants with documented partial response (PR) or better based on IWG criteria.

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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