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CompletedNCT01844869Updated Jan 30, 2015

An Open-Label Study to Investigate the Pharmacokinetics of Omacetaxine Mepesuccinate

A Phase 1 interventional study of omacetaxine mepesuccinate in Hematologic Malignancies and Solid Tumors, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-30.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the pharmacokinetic and safety profiles of omacetaxine and its metabolites in patients with relapsed and/or refractory hematologic malignancies or advanced solid tumors following subcutaneous (sc) administration.

Read the detailed description

This is a Phase 1, single-center, open-label, nonrandomized study to determine the pharmacokinetics (absorption, distribution, metabolism, and excretion) of omacetaxine and its metabolites following a sc dosage of 1.25 mg/m2 in adult patients with relapsed and/or refractory hematologic malignancies or advanced solid tumors. The study consists of a screening period of up to 28 days, followed by a 7-day pharmacokinetic assessment period (period A) that includes administration of a single radiolabeled dose of omacetaxine, an open-label treatment period of up to six 28-day cycles (period B), and a final assessment to occur approximately 28±7 days after the end of the last treatment cycle. Period B will begin after collection of the 72-hour pharmacokinetic sample during period A.

02

Conditions studied

  • Hematologic Malignancies
  • Solid Tumors

Keywords

  • omacetaxine
  • omacetaxine mepesuccinate
  • pharmacokinetics
  • hematologic malignancies
  • advanced solid tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent is obtained.
  • The patient is at least 18 years of age at the time of informed consent.
  • The patient has a histologically or cytologically confirmed diagnosis of any of the following:
  • Relapsed or refractory leukemia, including Philadelphia chromosome-positive (Ph+), chronic myelogenous leukemia (CML), acute promyelocytic leukemia (APL), acute myelogenous leukemia (AML), or myelodysplastic syndrome (MDS).
  • Advanced solid tumors (ie, breast, lung, head/neck, colorectal, melanoma, and sarcoma). The malignancy must be considered unresponsive to accepted available therapies.
  • The patient has an estimated life expectancy of at least 3 months.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Other criteria apply.

Exclusion criteria

Exclusion Criteria:

  • The patient has had chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy within 28 days prior to the first dose of study drug or has not recovered from adverse events due to any agents administered previously. For patients who received therapy with mitomycin C, the interval is 42 days.
  • The patient is receiving any other treatment for hematologic/nonhematologic malignancy.
  • The patient has had previous treatment with omacetaxine.
  • The patient has been treated with any hematopoietic growth factors within 14 days of study entry (patients on chronic erythropoiesis stimulating agents are allowed).
  • The patient has New York Heart Association (NYHA) Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure.
  • The patient has experienced a myocardial infarction within the previous 12 weeks.
  • The patient has a solid tumor with symptomatic central nervous system (CNS) metastases.
  • The patient has an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
  • Other criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    omacetaxine mepesuccinate

    Period A: 7-day pharmacokinetic assessment period in which all patients will be administered a single subcutaneous radiolabeled dose of 1.25-mg/m2 omacetaxine. Period B: omacetaxine will be administered as an sc injection at a dosage of 1.25 mg/m2 twice daily for 7 days (patients with solid tumors) or 14 days (patients with hematologic malignancies) of every 28-day cycle for up to 6 cycles.

    Drug: omacetaxine mepesuccinate

Interventions

  • Drugomacetaxine mepesuccinate

    Also known as: omacetaxine

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma drug concentrations (Cmax)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  2. Time to Reach Maximum Observed Plasma Drug Concentration (Tmax)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  3. Area under the plasma concentration by time curve (AUC) from time 0 to infinity (AUC0-∞)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  4. Area under the Curve from Time Zero to the Time of the Last Measurable Drug Concentration (AUC0-t)

    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  5. Terminal rate constant (λz) and associated half-life (t½)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  6. Percentage extrapolation calculated as (AUC0-∞-AUC0-t)/(AUC0-∞)x100

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  7. Apparent plasma clearance (CL/F)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

  8. Apparent volume of distribution (Vz/F)

    Time frame: 0,15, 30, and 45 minutes and 1, 2, 4, 8, 12, 24, 32, 48, 72, 96,120, 144, and 168 hours post dose

Secondary outcomes

  1. Summary of participants with adverse events

    Time frame: From Day 1 through the end of the follow-up period (28±7 days after 6 month treatment cycle)

07

Study locations

1 site
  • Teva Investigational Site 38045
    Amsterdam, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01844869
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party
Sponsor
First posted
May 1, 2013
Start date
Jul 2013
Primary completion
Dec 2014
Completion
Jan 2015
Last update
Jan 30, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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