Trial · NCT00045942
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
NCT00045942, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2017-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2). Trials, record NCT00045942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00045942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
- NCT number
- NCT00045942
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 144 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Interventions
- Itraconazole, PKC412
- First posted
- 2002-09-18
- Last updated
- 2017-08-11
- Results first posted
- 2017-07-17
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Core primary efficacy population: The core primary efficacy population included all participants who were randomized. | Participants | NUMBER |
| PRIMARY | Percent Decrease in Phospho-FLT3 Compared to Baseline (Core) | days 1, 28 | This outcome measure was not analyzed. Assessment of FLT3 autophosphorylation in leukemic blasts was not possible at the planned time points because the blast reduction was rapid and occurred during the first week in some participants. Thus, by Day 28, the blast count in some participants were too low for autophosphorylation to be measured. | ||
| PRIMARY | Number of Participants With Overall Clinical Response (E1) | from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004 | E1 primary efficacy population: all participants who received at least one dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population. | Participants | NUMBER |
| PRIMARY | Percent Decrease in Phospho-FLT3 Compared to Baseline (E1) | days 1, 28 | The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting. | ||
| PRIMARY | Percent Decrease in Phospho-FLT3 Compared to Baseline (E2) | Days 1, 28 | The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting. | ||
| 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 | The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed. | h*ng/ml | MEAN |
| 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 | The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed. | ng/ml | MEAN |
| 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 | The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed. | hour | MEDIAN |
| 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 | The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed. | h*ng/ml | MEAN |
| PRIMARY | Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2) | Cycle 1: days 21 and 22 | The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed. | hour | MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group214
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Best Clinical Response (Core) | PKC412 in FLT3 Mutated Participants (Core) | 0 | Participants | ||
| Number of Participants With Overall Clinical Response (E1) | FLT3 Mutated PKC412 100 mg/Day (E1) | Complete response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Mutated PKC412 200 mg/Day (E1) | Complete response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Wild Type PKC412 100 mg/Day (E1) | Complete response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Wild Type PKC412 200 mg/Day (E1) | Complete response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Mutated PKC412 100 mg/Day (E1) | Partial response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Mutated PKC412 200 mg/Day (E1) | Partial response | 1 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Wild Type PKC412 100 mg/Day (E1) | Partial response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Wild Type PKC412 200 mg/Day (E1) | Partial response | 0 | Participants | |
| Number of Participants With Overall Clinical Response (E1) | FLT3 Mutated PKC412 100 mg/Day (E1) | Minor response | 1 | Participants |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PKC412A2104 (Core) | STARTED | PKC412 in FLT3 Mutated Participants (Core) | 20 | |
| PKC412A2104 (Core) | STARTED | FLT3 Mutated PKC412 100 mg/Day (E1) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Mutated PKC412 200 mg/Day (E1) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Wild Type PKC412 100 mg/Day (E1) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Wild Type PKC412 200 mg/Day (E1) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Mutated PKC412 Dose Escalation (E2) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Mutated PKC+Itraconazole (E2) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Wild Type PKC412 Dose Escalation (E2) | 0 | |
| PKC412A2104 (Core) | STARTED | FLT3 Wild Type PKC+Itraconazole (E2) | 0 | |
| PKC412A2104 (Core) | Core Primary Efficacy | PKC412 in FLT3 Mutated Participants (Core) | 20 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events4,914
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PKC412 Core | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Mutated PKC412 100 mg/Day (E1) | 3 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Mutated PKC412 200 mg/Day (E1) | 1 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Wild Type PKC412 100 mg/Day (E1) | 7 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Wild Type PKC412 200 mg/Day (E1) | 3 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Mutated PKC412 Dose Escalation (E2) | 3 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Mutated PKC+Itraconazole (E2) | 0 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Wild Type PKC412 Dose Escalation (E2) | 4 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | FLT3 Wild Type PKC+Itraconazole (E2) | 4 | 6 | |
| other | Anaemia NOS | Blood and lymphatic system disorders | PKC412 Core | 4 | 20 |
1 to 10 of 4,914Source ClinicalTrials.gov
See all 4,914 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PKC412 Core | ||
| Total, all-cause mortality | FLT3 Mutated PKC412 100 mg/Day (E1) | ||
| Total, all-cause mortality | FLT3 Mutated PKC412 200 mg/Day (E1) | ||
| Total, all-cause mortality | FLT3 Wild Type PKC412 100 mg/Day (E1) | ||
| Total, all-cause mortality | FLT3 Wild Type PKC412 200 mg/Day (E1) | ||
| Total, all-cause mortality | FLT3 Mutated PKC412 Dose Escalation (E2) | ||
| Total, all-cause mortality | FLT3 Mutated PKC+Itraconazole (E2) | ||
| Total, all-cause mortality | FLT3 Wild Type PKC412 Dose Escalation (E2) | ||
| Total, all-cause mortality | FLT3 Wild Type PKC+Itraconazole (E2) | ||
| Total, other adverse events | PKC412 Core | 20 | 20 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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