Trial · NCT02782403
Axitinib and Bosutinib in Treating Patients With Chronic, Accelerated, or Blastic Phase Chronic Myeloid Leukemia
NCT02782403, Phase 1, Terminated, M.D. Anderson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Axitinib and Bosutinib in Treating Patients With Chronic, Accelerated, or Blastic Phase Chronic Myeloid Leukemia. Trials, record NCT02782403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02782403
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Axitinib and Bosutinib in Treating Patients With Chronic, Accelerated, or Blastic Phase Chronic Myeloid Leukemia
- NCT number
- NCT02782403
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 4 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Accelerated Phase Chronic Myelogenous Leukemia (CML), Blast Phase Chronic Myelogenous Leukemia (CML), Chronic Phase Phase Chronic Myelogenous Leukemia (CML), Philadelphia Chromosome Positive (Ph+) Phase Chronic Myelogenous Leukemia (CML)
- Interventions
- Axitinib, Bosutinib, Laboratory Biomarker Analysis
- First posted
- 2016-05-25
- Last updated
- 2020-11-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of major cytogenetic response (MCyR) among patients with chronic myeloid leukemia, chronic phase status post (s/p) failure of/intolerance to >= 3 tyrosine kinase inhibitors treated with alternating axitinib and bosutinib (Chronic Phase Cohort) | Up to 4 years | |
| Primary | Maximum tolerated doses of the combination of axitinib and bosutinib among patients with chronic myeloid leukemia (CML)-advanced phase (AP) or -blast phase (BP) (AP patients must have received >= 1 prior TKI) (Advanced phase cohort - Phase I Portion) | Up to 4 years | |
| Primary | Complete hematologic response (CHR) rate to the combination of axitinib and bosutinib among patients with CML-AP or -BP (AP patients must have received >= 1 prior TKI) (Advanced phase cohort - Phase II Portion) | Up to 4 years | |
| Secondary | Clinical rates analysis (Chronic Phase Cohort) | Up to 4 years | Rates of CHR, complete cytogenetic response (CCyR), major molecular response (MMR), molecular response 4-log (MR4), molecular response 4.5-log (MR4.5), complete molecular response (CMR), BCR-ABL/ABL =\< 10% and =\< 1%, duration of response (DOR), event-free survival (EFS), transformation-free survival (TFS), failure-free survival (FFS) and overall survival (OS) among patients with CML-CP after resistance and/or intolerance to \>= 2 TKIs treated with alternating axitinib and bosutinib. |
| Secondary | Incidence and severity of adverse events (AEs) (Advanced phase cohort - Phase I Portion) | Up to 4 years | Will be determined by history and physical examination and laboratory assessment, seen with the combination of axitinib and bosutinib among patients with CML-AP or -BP. |
| Secondary | Rates of CHR, CCyR, MMR, MR4, MR4.5, CMR, BCR-ABL/ABL =< 10% and =< 1%, DOR, EFS, TFS, FFS and OS among patients with CML-AP or -BP receiving combined therapy with axitinib and bosutinib (Advanced phase cohort - Phase II Portion) | Up to 4 years | |
| Secondary | Percentage of participants with mutations in BCR-ABL and other genes in all patients receiving study drugs | Baseline up to 4 years | Measured by analysis of each patient's multigene profile using Next Generation Sequencing (NGS) panel and/or ABL kinase domain sequencing performed at baseline. Following the analysis of each patient's mutation profile, the number of each somatic mutation identified will be reported. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02782403
GET https://conductscience.org/api/trials/v1/NCT02782403/registered