Phase I Trial of Cabozantinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01961765
Phase
PHASE1
Status
Completed

Conditions

  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This research study is evaluating a drug called cabozantinib as a possible treatment for acute myeloid leukemia (AML). This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. This means that the FDA has not approved giving cabozantinib for use in patients, including patients with your type of cancer. The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in the growth and multiplication of the cancerous cells associated with acute myeloid leukemia. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent cancer growth. The primary purpose of this research study is to determine the highest dose of Cabozantinib that can safely be given without severe or unmanageable side effects. The dose identified in this study will be used in future research studies that seek to determine the role of cabozantinib as a treatment for AML.

Key Dates

Start date
Nov 30, 2013
Status verified
Jul 2017
Primary completion
May 31, 2016
Completion
Jan 31, 2017

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cabozantinib
    Cabozantinib will be administered at a dose of 40mg daily by mouth in the first cohort. Dose escalation will occur in subsequent patient cohorts. We will evaluate 3-6 patients per dose level.

Primary Outcome Measure

Maximum tolerated dose (MTD) of cabozantinib in patients with advanced acute myeloid leukemia [ Time Frame: 2 Years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02215-

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By research site
Beth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MA

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