The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05638763
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Collaborator:
Fernando De la Garza Salazar
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia. Researchers will describe response rates and adverse events.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia, Chronic Phase Drug: Dasatinib Pill Drug: Ketoconazole Pill Phase 2

Detailed Description:

Dasatinib is a second-generation tyrosine kinase inhibitor that is metabolized by the cytochrome P450. Dasatinib has shown efficacy in patients with chronic myelogenous leukemia. Standard-dose dasatinib is 50mg-140mg/day orally, continuously. However, when combined with a strong CYP3A4 inhibitor, a dose reduction of 75% is warranted.

This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce the dosage and costs of dasatinib for adults with chronic myelogenous leukemia. Researchers will describe cytogenetic and molecular response rates at 3, 6, and 12 months and adverse events (i.e., pleural effusion) associated with this strategy.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia
Estimated Study Start Date : November 2024
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dasatinib and ketoconazole
Patients will receive dasatinib at a dose of 25mg orally daily for one year and ketoconazole 200mg orally two times per day for one year.
 Drug: Dasatinib Pill
Patients will receive half pill of dasatinib 50mg (25mg/day, orally) for one year
Other Name: Sprycel

Drug: Ketoconazole Pill
Patients will receive ketoconazole 200mg two times a day, orally, for one year.
Other Name: Nizoral


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The rate of Complete Cytogenetic Response [ Time Frame: Up to 6 months ]
    B-cell antigen receptor(BCR)/Tyrosine-protein kinase-ABL1(ABL1) IS <=1% at 6 months


Secondary Outcome Measures :
  1. The rate of Molecular Response (MR4) [ Time Frame: Up to 6 months ]
    Log reduction in BCR/ABL of 4

  2. The rate of Molecular Response (MR4.5) [ Time Frame: Up to 6 months ]
    Log reduction in BCR/ABL of 4.5

  3. The rate of sustained Molecular Response (MR4.5) [ Time Frame: Up to 12 months ]
    Log reduction in BCR/ABL of 4.5

  4. The proportion of non hematological side effects [ Time Frame: Up to 12 months ]
    Proportion of patients that presented non hematological side effects to the intervention

  5. The rate of Complete Cytogenetic Response [ Time Frame: Up to 12 months ]
    BCR/ABL IS <=1% at 12 months


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016
  3. Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

  1. Chronic heart disease (NYHA III-IV)
  2. Bleeding disorders not attributed to the hematological malignancy
  3. Pregnancy
  4. Lactation
  5. Chronic myeloid leukemia in blast phase
  6. Organic dysfunction (Marshall score ≥2)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05638763


Contacts
Layout table for location contacts
Contact: Fernando De la Garza Salazar, MD (52) 811 080 2131 fernandodelagarza@gmail.com

Locations
Layout table for location information
Mexico
Hospital Universitario Dr. José Eleuterio González Recruiting
Monterrey, Nuevo Leon, Mexico, 64630
Contact: Dr Fernando De la Garza Salazar, MD    8442322102    fernandodelagarza@gmail.com   
Contact: Fernando De la Garza Salazar, MD    8442322102      
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Fernando De la Garza Salazar
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: David Gomez Almaguer, Head of Department, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT05638763    
Other Study ID Numbers: HE22-00031
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Ketoconazole
Dasatinib
Tyrosine Kinase Inhibitors
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors