Trial · NCT00045942
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Best Clinical Response (Core) | from date of first patient first visit (FPFV), 29-Jan-2002, to date of last participant last visit (LPLV), 04-Sep-2003 | Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS. |
| Primary | Percent Decrease in Phospho-FLT3 Compared to Baseline (Core) | days 1, 28 | |
| Primary | Number of Participants With Overall Clinical Response (E1) | from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004 | Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS. |
| Primary | Percent Decrease in Phospho-FLT3 Compared to Baseline (E1) | days 1, 28 | |
| Primary | Percent Decrease in Phospho-FLT3 Compared to Baseline (E2) | Days 1, 28 | |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for PKC412 Plasma in the PKC + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for pharmacokinetic (PK) analysis. |
| Primary | Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for pharmacokinetic (PK) analysis. |
| Primary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for PK analysis. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for PK analysis. |
| Primary | Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2) | Cycle 1: days 21 and 22 | Blood samples were collected for PK analysis. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP62221 Plasma in the PKC + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for pharmacokinetic (PK) analysis. |
| Primary | Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for pharmacokinetic (PK) analysis. |
| Primary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for PK analysis. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP622221 in the PKC412 + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for PK analysis. |
| Primary | Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2) | Cycle 1: day 22, | Blood samples were collected for PK analysis. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP52421 Plasma in the PKC + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for pharmacokinetic (PK) analysis. |
| Primary | Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP52421 in the PKC + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for pharmacokinetic (PK) analysis. |
| Primary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for PK analysis. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2) | Cycle 1: days 21, 22, 28 | Blood samples were collected for PK analysis. |
| Primary | Summary of Midostaurin Concentration in the PKC412 Dose Escalation Arms(E2) | Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15 | Blood samples were collected for analysis. |
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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