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Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

NCT02109627 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-03-24

No results posted yet for this study

Summary

The purpose of this study is to see if ficlatuzumab when combined with cytarabine, a standard treatment for AML, is safe to give to patients and to determine the best dose to give. The study doctors want to see what effects, good and/or bad, the study drug has on subjects and their AML. The study will look at what side effects subjects may have and how subjects feel after receiving the study drug.

Conditions

Interventions

DRUG

Ficlatuzumab

5-20 mg/kg; intravenous; Days 0, 14, 28, and 42. Number of cycles: until progression or unacceptable toxicity develops.

DRUG

Cytarabine

2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • AVEO Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Gateway for Cancer Research

    collaborator OTHER

  • C. Babis Andreadis

    lead OTHER

Principal Investigators

  • Charalambos Andreadis, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2019-12-02
Completion
2019-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109627 on ClinicalTrials.gov