Phase 3
Completed N=191
Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib
Source: ClinicalTrials.gov NCT00802841 ↗Enrolled (actual)
191
Serious AEs
9.7%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With Complete Cytogenetic Response (CCyR) — 50.0; 42.1 Percentage of participants — p=0.3106
Summary
There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Cytogenetic Response (CCyR) |
50.0; 42.1 | 0.3106 |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) |
36.5; 25.3; 37.5; 35.8 | — |
| SECONDARY Percentage of Participants With CCyr |
53.1; 55.8; 51.0; 61.1 | — |
| SECONDARY Time to CCyR |
5.55; 5.85 | — |
| SECONDARY Duration of CCyR |
NA; 17.2 | — |
| SECONDARY Progression-Free Survival (PFS) |
NA; NA | — |
| SECONDARY Event-Free Survival (EFS) |
NA; 24.3 | — |
| SECONDARY Overall Survival (OS) |
NA; 25.7 | — |
Eligibility Criteria
Inclusion criteria
- Male or female ≥ 18 years old;
- ECOG of 0, 1, or 2;
- Ph+ CML in CP defined as:
- 95% Ph+ metaphases);or
- No PCyR at ≥ 6 to 450 msec on screening ECG (using the QTcF formula). If QTc >450 and electrolytes are not with normal ranges, electrolytes should be corrected and then the patient rescreened for QTc to certify QTc <450 msec;
- Myocardial infarction ≤ 12 months prior to the first dose of study drug;
- Other clinically significant heart disease (e.g., CHF, uncontrolled hypertension, unstable angina, significant ventricular or atrial tachyarrhythmias) 10. Impairment of GI function or disease that may significantly alter the absorption of study drug; 11. Treated with strong CYP3A4 inhibitors that cannot be either discontinued or switched to a different medication prior to starting study drug; 12.Currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug; 13.History of previous acute pancreatitis within one year of study entry or medical history of chronic pancreatitis; 14.Known cytopathologically confirmed CNS 15.Women who are pregnant, breast feeding or of a childbearing potential without a negative urine pregnancy test at screening. Female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial and for 3 months post trial end. Post-menopausal women must be ammenorrheic for at least 12 months to be considered of non-childbearing potential; 16. History of another primary malignancy that is currently clinically significant or currently requires active intervention; 17.Any other clinically significant medical or surgical condition which, according to investigators' discretion, should preclude participation; 18.Use of investigational agent within 28 days prior to enrollment; 19.Patients unwilling or unable to comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT00802841). 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.