NCT00045942 is a Phase 1, PHASE2 clinical trial of Itraconazole in Acute Myeloid Leukemia, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT00045942?

NCT00045942 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT00045942?

Interventions in NCT00045942: Itraconazole, PKC412.

What condition does NCT00045942 study?

NCT00045942 studies Acute Myeloid Leukemia, Myelodysplastic Syndromes.

Is NCT00045942 still recruiting?

NCT00045942 is currently completed. Last updated 11 August 2017.

Are results published for NCT00045942?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-11 · How we verify

NCT00045942

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 1, PHASE2 Results posted Last updated 11 August 2017

What this trial tests

Phase 1, PHASE2 trial testing Itraconazole in Acute Myeloid Leukemia in 144 participants. Completed in 27 March 2008.

Timeline

30 January 2002

Primary endpoint
27 March 2008

27 March 2008

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	144
Start date	30 January 2002
Primary completion	27 March 2008
Estimated completion	27 March 2008
Sites	4 locations across United States

Drugs / interventions tested

Itraconazole — full drug profile →
PKC412 — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Best Clinical Response (Core) Primary · 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.

Group	Value	95% CI
PKC412 in FLT3 Mutated Participants (Core)	0

Number of Participants With Overall Clinical Response (E1) Primary · 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.

Complete response

Group	Value	95% CI
FLT3 Mutated PKC412 100 mg/Day (E1)	0
FLT3 Mutated PKC412 200 mg/Day (E1)	0
FLT3 Wild Type PKC412 100 mg/Day (E1)	0
FLT3 Wild Type PKC412 200 mg/Day (E1)	0

Partial response

Group	Value	95% CI
FLT3 Mutated PKC412 100 mg/Day (E1)	0
FLT3 Mutated PKC412 200 mg/Day (E1)	1
FLT3 Wild Type PKC412 100 mg/Day (E1)	0
FLT3 Wild Type PKC412 200 mg/Day (E1)	0

Minor response

Group	Value	95% CI
FLT3 Mutated PKC412 100 mg/Day (E1)	1
FLT3 Mutated PKC412 200 mg/Day (E1)	0
FLT3 Wild Type PKC412 100 mg/Day (E1)	6
FLT3 Wild Type PKC412 200 mg/Day (E1)	3

Blast response

Group	Value	95% CI
FLT3 Mutated PKC412 100 mg/Day (E1)	11
FLT3 Mutated PKC412 200 mg/Day (E1)	12
FLT3 Wild Type PKC412 100 mg/Day (E1)	15
FLT3 Wild Type PKC412 200 mg/Day (E1)	8

Overall response

Group	Value	95% CI
FLT3 Mutated PKC412 100 mg/Day (E1)	12
FLT3 Mutated PKC412 200 mg/Day (E1)	13
FLT3 Wild Type PKC412 100 mg/Day (E1)	21
FLT3 Wild Type PKC412 200 mg/Day (E1)	11

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) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for pharmacokinetic (PK) analysis.

Cycle 1, day 21 (n=9)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	22261.53	± 11984.6

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	37578.85	± 44330.7

Cycle 1, day 28 (n=7)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	35630.45	± 23993.2

Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for pharmacokinetic (PK) analysis.

Cycle 1 , day 21 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3945.00	± 4440.238

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3968.70	± 4047.498

Cycle 1, day 28 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3931.25	± 2638.135

Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for PK analysis.

Cycle 1, day 21 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	1.6	1.0 – 8.1

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	1.9	1.2 – 4.7

Cycle 1, day 28 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	2.2	0.0 – 3.3

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) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for PK analysis.

Cycle 1, day 21 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	32120.58	± 35792.2

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	34684.6	± 37084.9

Cycle 1, day 28, (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	33020.17	± 17206.3

Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2) Primary · Cycle 1: days 21 and 22

Blood samples were collected for PK analysis.

Cycle 1, day 21 (n=6)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	18.13	± 13.505

Cycle 1, day 22 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	13.23	± 6.346

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) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for pharmacokinetic (PK) analysis.

Cycle 1, day 21 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	30217.82	± 16502.90

Cycle 1, day 22 (n=7)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	23824.69	± 13300.69

Cycle 1, day 28 (n=7)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	31545.54	± 12453.16

Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for pharmacokinetic (PK) analysis.

Cycle 1, day 21 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3259.30	± 1747.923

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3221.40	± 1980.217

Cycle 1, day 28 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3032.25	± 1975.371

Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for PK analysis.

Cycle 1, day 21 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3.7	0.0 – 10.3

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	2.3	0.0 – 6.1

Cycle 1, day 28 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	3.3	0.0 – 8.5

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) Primary · Cycle 1: days 21, 22, 28

Blood samples were collected for PK analysis.

Cycle 1, day 21 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	31699.93	± 15573.87

Cycle 1, day 22 (n=10)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	31182.90	± 17380.39

Cycle 1, day 28 (n=8)

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	26688.60	± 10901.40

Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2) Primary · Cycle 1: day 22,

Blood samples were collected for PK analysis.

Group	Value	95% CI
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined	14.37	± 6.743

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PKC412 Core

Serious: 12/20 (60%)

Deaths: —

FLT3 Mutated PKC412 100 mg/Day (E1)

Serious: 16/18 (89%)

Deaths: —

FLT3 Mutated PKC412 200 mg/Day (E1)

Serious: 14/17 (82%)

Deaths: —

FLT3 Wild Type PKC412 100 mg/Day (E1)

Serious: 22/33 (67%)

Deaths: —

FLT3 Wild Type PKC412 200 mg/Day (E1)

Serious: 19/27 (70%)

Deaths: —

FLT3 Mutated PKC412 Dose Escalation (E2)

Serious: 7/9 (78%)

Deaths: —

FLT3 Mutated PKC+Itraconazole (E2)

Serious: 6/7 (86%)

Deaths: —

FLT3 Wild Type PKC412 Dose Escalation (E2)

Serious: 5/7 (71%)

Deaths: —

FLT3 Wild Type PKC+Itraconazole (E2)

Serious: 3/6 (50%)

Deaths: —

Serious adverse events (222 terms)

Reaction	System	PKC412 Core	FLT3 Mutated PKC412 100 mg…	FLT3 Mutated PKC412 200 mg…	FLT3 Wild Type PKC412 100 …	FLT3 Wild Type PKC412 200 …	FLT3 Mutated PKC412 Dose E…	FLT3 Mutated PKC+Itraconaz…	FLT3 Wild Type PKC412 Dose…	FLT3 Wild Type PKC+Itracon…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Staphylococcal infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Blast cell count increased	Investigations	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—	—	—	—	—

Other adverse events (324 terms — click to expand)

Reaction	System	PKC412 Core	FLT3 Mutated PKC412 100 mg…	FLT3 Mutated PKC412 200 mg…	FLT3 Wild Type PKC412 100 …	FLT3 Wild Type PKC412 200 …	FLT3 Mutated PKC412 Dose E…	FLT3 Mutated PKC+Itraconaz…	FLT3 Wild Type PKC412 Dose…	FLT3 Wild Type PKC+Itracon…
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting NOS	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Diarrhoea NOS	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Gingival bleeding	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Anaemia NOS	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Coagulopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Pneumonia, Pyrexia, Sepsis, Hypoxia, Anaemia, Thrombocytopenia, Hypotension.

Data from ClinicalTrials.gov NCT00045942 adverse events section.

Sponsor's own description

CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2. The trial was to be stopped if no participants showed a response in stage 1. POC was achieved if at least 2 participants out of 12 responded. In PKC412A2104E1, participants with AML or high risk MDS with wild-type or mutant FTL3 who had not previously received a FLT3 inhibitor were randomized to receive continuous twice daily oral doses of either 50 or 100 mg midostaurin in 1 28-day cycle regimen. Participants were to be treated until disease progression or the occurrence of unacceptable treatment-related toxicity. PKC412A2104 E2 contained 2 dosing regimens: 1) intra-participant midostaurin dose escalation and 2) midostaurin with itraconazole in participants with AML and high risk MDS irrespective of FLT3 status. Eligible participants were alternately assigned to the regimens. At the Investigator's discretion, intra-participant dose escalation was allowed for any previously enrolled CPKC412A2104E1 participant receiving midostaurin at the time of the approval of amendment 4. Participants were treated until the time of disease progression.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00045942 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 11 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00045942.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00045942

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (222 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Itraconazole

Other recruiting trials for Acute Myeloid Leukemia

Other Novartis Pharmaceuticals trials

Verify against primary sources