Phase 2
N=100
Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML
Chronic Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00462943 ↗Enrolled (actual)
100
Serious AEs
63.0%
Results posted
Jun 2014
Primary outcome: Primary: Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population — 67.4; 25.8; 8.7; 41.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omacetaxine mepesuccinate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population |
67.4; 25.8; 8.7; 41.0 | — |
| PRIMARY Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population |
21.7; 3.2; 0; 11 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total |
46; 31; 23; 100; 26; 19 | — |
| SECONDARY Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+) |
4.3; 0; 0; 2.0; 17.4; 3.2 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS |
13.6; 0; 0; 6.8 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL |
10.5; 4.3; 0; 6.9 | — |
| SECONDARY Percentage of Participants in Each Hematologic Response Category |
67.4; 19.4; 8.7; 39.0; 0; 3.2 | — |
| SECONDARY Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response |
0; 50 | — |
| SECONDARY Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Treatment Cycles Needed to Achieve Best Hematologic Response |
1.0; 2.0; 2.0; 1.0 | — |
| SECONDARY Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response |
2.0; 1.5; 1.0; 2.0 | — |
| SECONDARY Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response |
1.38; NA; NA; 5.03 | — |
| SECONDARY Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response |
NA; NA; NA | — |
| SECONDARY Kaplan-Meier Estimates for Duration of Best Hematologic Response |
7.01; 5.47; 2.67 | — |
| SECONDARY Kaplan-Meier Estimates for Duration of Best Cytogenetic Response |
6.01; 0.07 | — |
| SECONDARY Kaplan-Meier Estimates for Time to Disease Progression |
7.50; 4.84; 2.04; 4.38 | — |
| SECONDARY Kaplan-Meier Estimates for Overall Survival |
33.91; 17.27; 3.52; 17.27 | — |
Summary
A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.
Eligibility Criteria
Inclusion Criteria
- Male or female patients, age 18 years or older
- Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
- Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
- Acceptable Renal and Liver Function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Sexually active patients and their partners must use an effective double barrier method of contraception
Exclusion Criteria
- New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
- Myocardial infarction in the previous 12 weeks.
- Other concurrent illness which would preclude study conduct and assessment
- uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not.
- Pregnant or lactating.
- Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
- Lymphoid Ph+ blast crisis
- Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
Data sourced from ClinicalTrials.gov (NCT00462943). 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.