Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Study of PKC412 With or Without Itraconazole in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-02021 NOVARTIS-CPKC412A2104, NCI-G02-2107, UCLA-0305058-01, NCT00045578

Trial Description

Purpose:

PKC412 and itraconazole may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Phase I/II trial to study the effectiveness of PKC412 with or without itraconazole in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• At least 2 months since bone marrow transplantation or stem cell transplantation
• At least 1 week since hydroxyurea
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be assigned to one of two groups.

Patients in group one will receive PKC412 by mouth twice a day.

Patients in group two will receive PKC412 by mouth twice a day. Beginning in week 4, they will also receive itraconazole by mouth twice a day.

Treatment in both groups may continue for as long as benefit is shown. Patients will be evaluated every 3 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Virginia Klimek, MD, Protocol chair		Ph: 212-639-6519; 800-525-2225

Jonsson Comprehensive Cancer Center at UCLA

Gary Schiller, MD, Principal investigator		Ph: 310-825-5513; 888-798-0719 Email: garyjs@ucla.edu

Registry Information
Official Title		An Open-Label, Phase II (Proof Of Concept) Trial Of PKC412 Monotherapy In Patients With Acute Myeloid Leukemia (AML) And Patients With High Risk Myelodysplastic Syndrome (MDS)
Trial Start Date		2002-03-12
Registered in ClinicalTrials.gov		NCT00045578
Date Submitted to PDQ		2002-07-16
Information Last Verified		2005-05-04
NCI Grant/Contract Number		P30-CA08748

Back to Top