N/A
Completed N=820
Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008
Source: ClinicalTrials.gov NCT01903733 ↗Enrolled (actual)
820
Serious AEs
45.0%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0) — 241; 283; 119; 165 Participants
Summary
The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0) |
241; 283; 119; 165; 808; 102 | — |
| PRIMARY Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0) |
191; 223; 84; 144; 642 | — |
| PRIMARY Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0) |
235; 282; 119; 161; 797 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03) |
45; 59; 28; 18; 150; 86 | — |
| PRIMARY Number of Participants With Adverse Events as Reason for Treatment Discontinuation |
84; 79; 37; 32; 232 | — |
| PRIMARY Number of Participants With Diarrhea After Switch From Bosutinib Clinical Formulation to Bosutinib Commercial Formulation |
25; 22; 3; 5; 55; 34 | — |
| PRIMARY Number of Participants With Breakpoint Cluster Region Abelson Protooncogene (BCR-ABL) Mutations Present at Time of Bosutinib Treatment Discontinuation |
7; 28; 13; 14 | — |
| PRIMARY Overall Survival (OS) Rate at Year 10 |
88.2; 71.5; 60.4; 34.2 | — |
| PRIMARY Plasma Steady-State Trough Concentrations (Ctrough) of Bosutinib |
62.2; 62.0; 82.2; 93.3; 99.4 | — |
| PRIMARY Kaplan-Meier Estimate of Probability of Maintaining Major Cytogenetic Response (MCyR) at Year 10: B1871006 Participants |
65.3; 55.3; 30.6 | — |
| PRIMARY Kaplan-Meier Estimate of Probability of Maintaining Complete Cytogenetic Response (CCyR) at Year 10: B1871006 Participants |
63.4; 40.8; 29.6 | — |
| PRIMARY Kaplan-Meier Estimate of Probability of Maintaining Complete Hematologic Response (CHR) at Year 10: B1871006 Participants |
44.1; 45.1; NA | — |
| PRIMARY Cumulative Incidence of Progression/Death Events at Year 10: B1871006 Participants |
23.9; 26.9; 55.7 | — |
| PRIMARY Cumulative Incidence of Rate of Transformation to Accelerated Phase (AP) or Blast Phase (BP) at Year 10: B1871006 Participants |
5.3; 4.2; 3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.
Exclusion Criteria
- All subjects are excluded unless previously participating in studies B1871006 or B1871008.
Data sourced from ClinicalTrials.gov (NCT01903733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.