NCT01332786

Brief Summary

The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

3.6 years

First QC Date

March 31, 2011

Last Update Submit

April 14, 2015

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

  • Toxicity evaluated according to CTCAE version 4.03

    Reviewed at each visit and assessed at the end of each 3-week cycle

Secondary Outcomes (1)

  • Response rate assessment of tigecycline through laboratory assessments

    Assessed at the end of each 3-week cycle for the study duration

Study Arms (1)

Tigecycline

EXPERIMENTAL
Drug: Tigecycline

Interventions

TigecyclineDRUG

Dosage Form: one-hour intravenous infusion Dosage levels, frequency, duration: (3-week cycles) * Level 1: 50 mg daily x 10 doses; 1 week rest * Level 2: 100 mg daily x 10 doses; 1 week rest * Level 3: 150 mg daily x 10 doses; 1 week rest * Level 4: 200 mg daily x 10 doses 1 week rest * Level 5: 250 mg daily x 10 doses; 1 week rest * Level 6: 300 mg daily x 10 doses; 1 week rest * Level 7: 350 mg daily x 10 doses; 1 week rest

Also known as: Tygacil
Tigecycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Diagnosis of relapsed or refractory AML for which all potentially curative or standard salvage therapy options have been exhausted; OR AML without prior treatment who are not eligible for induction chemotherapy as defined as age \> or equal to 80 or age \> 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as LVEF less than 40% and/or DlCO less than 60% expected
  • ECOG 0-2 performance status
  • Biochemical values within the following range
  • Serum creatinine \<2x upper limit of normal
  • Total bilirubin \<1.5x upper limit of normal
  • AST and ALT \<2x upper limit of normal
  • Recovery from non-hematologic toxicity from prior chemotherapy
  • Able and willing to provide informed consent

You may not qualify if:

  • Allergy to tetracycline or minocycline
  • Uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection
  • Active systemic bacterial, fungal, or viral infection
  • Concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis
  • Pregnant or breast feeding
  • Known active CNS involvement with AML
  • Neurologic symptoms related to uncontrolled illnesses or unexplained causes
  • Psychiatric illness that would limit compliance with study
  • Receiving systemic chemotherapy other than hydroxyurea to control circulating blast counts. Concomitant hydroxyurea is permitted, but only in the first cycle of therapy
  • Prior therapy with tigecycline as an anti-cancer therapy or any use of the drug in the last month
  • Use of other investigational anti-leukemic therapy within 14 days of registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Aaron Schimmer, MD

    University Health Network, Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 11, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(2)CA(1)