Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

March 22, 2020 updated by: C. Babis Andreadis

Phase Ib Study of Ficlatuzumab With High Dose Cytarabine (HiDAC) in Relapsed and Refractory AML

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Relapsed or refractory AML as defined by one of the following criteria:

    1. First relapse within 12 months after date of first Complete Response (CR) or complete repsonse with incomplete hematologic recovery (CRi)
    2. Persistent AML documented by bone marrow biopsy at least 28 days after day 1 of the first induction cycle of cytotoxic chemotherapy
    3. Hypercellular bone marrow with greater than 20% cellularity and 10% blasts at least 14 days after first induction cycle day 1
  • Age >=18
  • Prior induction therapy had to include no more than two cycles of cytotoxic chemotherapy and at least one induction cycle must have consisted of an anthracycline or anthracenedione and cytarabine combination with a reasonable schedule/dose according to the discretion of the investigator
  • Histologically confirmed AML by hematopathology review performed within four weeks prior to study entry
  • Ejection fraction >=40% by transthoracic echocardiogram or radionuclide ventriculogram, i.e. multigated acquisition (MUGA) scan
  • Treatment for non-hematologic malignancy greater than 6 months prior to enrollment is acceptable.
  • Transplantation for AML (allogeneic or autologous) allowed unless within 90 days of study entry
  • No active graft versus host disease (GVHD) or immunosuppression for prevention or treatment of GVHD within two weeks of study entry
  • Prior treatment of myelodysplastic syndrome or myeloproliferative neoplasm with hypomethylating agent acceptable.
  • Cytoreduction therapy with plasmapheresis or hydroxyurea acceptable.
  • Females must have a negative serum pregnancy test 24 hours prior to the start of treatment or be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months)
  • Adequate liver function as defined by total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilbert's syndrome) and aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 times upper limit of normal, unless these are thought to be due to AML
  • Adequate renal function with creatinine ≤ 2.0 mg/dL
  • The effects of ficlatuzumab on the developing human fetus are unknown. For this reason and because cytarabine is pregnancy category D, women of child-bearing potential and men must agree to use adequate contraception: hormone, barrier method of birth control, or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and at least one month after completion of study drug administration.
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

  • Acute promyelocytic leukemia (FAB M3 AML)
  • More than 2 cycles of prior induction therapy for AML
  • Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days of study entry or on active immunosuppressive therapy for graft versus host disease (GVHD) within 2 weeks before study entry
  • Cytarabine containing regimen in excess of 2 g/m2/day within 6 months of study entry
  • Chemotherapy, radiation, or immunotherapy, within 2 weeks prior to study entry, other than those specified in the inclusion criteria (hydroxyurea and hypomethylating agents)
  • Known active HIV, hepatitis B or C or infection. Exception for patients with hepatitis B on antivirals and low viral load, to be determined at the discretion of the investigator.
  • Uncontrolled infection
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
  • Active second malignancy that in the opinion of the PI may interfere with or be adversely affected by this treatment.
  • Prior exposure to the investigational agent or anti-c-Met, anti-HGF or anti-VEGF directed therapy within six months prior to study entry
  • Prior grade 4 toxicity attributed to cytarabine
  • Known or suspected drug sensitivity to cytarabine or the investigational agent ficlatuzumab
  • Inability to provide consent
  • Pregnant women are excluded from this study because the effect of ficlatuzumab on the developing fetus remains unknown and that cytarabine is a pregnancy risk category D drug with known teratogenic or abortifacient effects. Because of the potential adverse events in nursing infants secondary to treatment of the mother with ficlatuzumab and cytarabine, breastfeeding should be discontinued while on study. Patients who become pregnant while on study will be removed from the study once the pregnancy is confirmed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ficlatuzumab, Cytarabine

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose-Limiting Toxicity (DLT) for ficlatuzumab when administered with HiDAC
Time Frame: Up to 2 years
Up to 2 years
Maximum Tolerated Dose (MTD) for ficlatuzumab when administered with HiDAC
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Preliminary activity of ficlatuzumab in combination with HiDAC in patients with relapsed or refractory AML
Time Frame: Up to 2 years
Up to 2 years
Functional status for patients receiving ficlatuzumab and HiDAC
Time Frame: Up to 2 years
Up to 2 years
Quality of life for patients receiving ficlatuzumab and HiDAC
Time Frame: Up to 2 years
Up to 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Overall survival of patients receiving ficlatuzumab in combination with HiDAC
Time Frame: Up to 2 years
Up to 2 years
Candidate biomarkers for response to combination therapy
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. Babis Andreadis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gateway for Cancer Research
AVEO Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charalambos Andreadis, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 139510
  • NCI-2015-00749 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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