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Acute Myeloid LeukemiaPhase 1NCT02109627

Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

A Phase 1 study testing Ficlatuzumab and Cytarabine in people with Acute Myeloid Leukemia and Relapsed Acute Myeloid Leukemia, run by C. Babis Andreadis at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ficlatuzumab and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
1 May 2015to 2 Dec 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or refractory AML as defined by one of the following criteria:
  • First relapse within 12 months after date of first Complete Response (CR) or complete repsonse with incomplete hematologic recovery (CRi)
  • Persistent AML documented by bone marrow biopsy at least 28 days after day 1 of the first induction cycle of cytotoxic chemotherapy
  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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.

Being tested
Ficlatuzumab, Cytarabine
Keywords
Acute Myeloid Leukemia, Ficlatuzumab, High Dose Cytarabine, antibody
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FiclatuzumabDrug

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

  • CytarabineDrug

    Also called HiDAC

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

Study groups in NCT02109627
Study groupRoleWhat they receive
Ficlatuzumab, CytarabineExperimentalFiclatuzumab 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.
Receives: Drug: Ficlatuzumab; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT) for ficlatuzumab when administered with HiDAC

    Measured: Up to 2 years

  2. Maximum Tolerated Dose (MTD) for ficlatuzumab when administered with HiDAC

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Preliminary activity of ficlatuzumab in combination with HiDAC in patients with relapsed or refractory AML

    Measured: Up to 2 years

  2. Functional status for patients receiving ficlatuzumab and HiDAC

    Measured: Up to 2 years

  3. Quality of life for patients receiving ficlatuzumab and HiDAC

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study start1 May 2015
  3. Primary completion2 Dec 2019
  4. Study completion2 Dec 2019

Why it stopped: Low Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02109627
Sponsor's protocol ID
139510
Other IDs
NCI-2015-00749
Status last verified
Mar 2020
First submitted
23 Jan 2014
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ficlatuzumab and Cytarabine in people with Acute Myeloid Leukemia and Relapsed Acute Myeloid Leukemia, run by C. Babis Andreadis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low Accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) for ficlatuzumab when administered with HiDAC (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02109627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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