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NCT05638763
Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia
Phase 2 trial testing Dasatinib Pill in Chronic Myeloid Leukemia, Chronic Phase in 15 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Hospital Universitario Dr. Jose E. Gonzalez |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 November 2024 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 November 2024 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Dasatinib Pill — full drug profile →
- Ketoconazole Pill — full drug profile →
Conditions studied
- Chronic Myeloid Leukemia, Chronic Phase — all drugs for Chronic Myeloid Leukemia, Chronic Phase →
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Who can join
18 and older, any sex, with Chronic Myeloid Leukemia, Chronic Phase. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmacokinetic Boosting of Kinase Inhibitors.
Westra N, Touw D, Lub-de Hooge M, Kosterink J, et al · · 2023 · cited 17× · PMID 37111635 · DOI 10.3390/pharmaceutics15041149 -
Focal adhesion in the tumour metastasis: from molecular mechanisms to therapeutic targets.
Liu Z, Zhang X, Ben T, Li M, et al · · 2025 · cited 12× · PMID 40045379 · DOI 10.1186/s40364-025-00745-7
Verify or expand the search:
- PubMed search for NCT05638763
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Myeloid Leukemia, Chronic Phase
Currently open trials in the same condition.
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- NCT06368414 — A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia · Phase 2 · recruiting
- NCT06119269 — Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase · recruiting
- NCT06233890 — The Analysis of Fatigue on Tyrosine Kinase Inhibitor Therapy in Chronic Myeloid Leukaemia · active not recruiting
- NCT03722420 — Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China) · Phase 3 · active not recruiting
Other Hospital Universitario Dr. Jose E. Gonzalez trials
Trials by the same sponsor.
- NCT07401992 — Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis · Phase 4 · recruiting
- NCT06758375 — Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients · Phase 2 · recruiting
- NCT06904599 — Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment · Phase 2 · recruiting
- NCT07039877 — Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients · Phase 2 · recruiting
- NCT06209190 — Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05638763 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario Dr. Jose E. Gonzalez
- Last refreshed: 25 November 2022
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/NCT05638763.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing