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Ficlatuzumab With High Dose Cytarabine in Relapsed and Refractory AML

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ClinicalTrials.gov Identifier: NCT02109627
Recruitment Status : Active, not recruiting
First Posted : April 10, 2014
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
AVEO Pharmaceuticals, Inc.
Gateway for Cancer Research
Information provided by (Responsible Party):
C. Babis Andreadis, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Relapsed Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Drug: Ficlatuzumab Drug: Cytarabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study of Ficlatuzumab With High Dose Cytarabine (HiDAC) in Relapsed and Refractory AML
Actual Study Start Date : January 23, 2014
Estimated Primary Completion Date : December 27, 2019
Estimated Study Completion Date : June 26, 2020


Arm Intervention/treatment
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 Name: HiDAC




Primary Outcome Measures :
  1. Dose-Limiting Toxicity (DLT) for ficlatuzumab when administered with HiDAC [ Time Frame: Up to 2 years ]
  2. Maximum Tolerated Dose (MTD) for ficlatuzumab when administered with HiDAC [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Preliminary activity of ficlatuzumab in combination with HiDAC in patients with relapsed or refractory AML [ Time Frame: Up to 2 years ]
  2. Functional status for patients receiving ficlatuzumab and HiDAC [ Time Frame: Up to 2 years ]
  3. Quality of life for patients receiving ficlatuzumab and HiDAC [ Time Frame: Up to 2 years ]

Other Outcome Measures:
  1. Overall survival of patients receiving ficlatuzumab in combination with HiDAC [ Time Frame: Up to 2 years ]
  2. Candidate biomarkers for response to combination therapy [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    1. First relapse within 12 months after date of first CR or 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. 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 AST/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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109627


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
C. Babis Andreadis
AVEO Pharmaceuticals, Inc.
Gateway for Cancer Research
Investigators
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Principal Investigator: Charalambos Andreadis, MD University of California, San Francisco

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Responsible Party: C. Babis Andreadis, Associate Professor of Clinical Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02109627     History of Changes
Other Study ID Numbers: 139510
NCI-2015-00749 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C. Babis Andreadis, University of California, San Francisco:
Acute Myeloid Leukemia
Ficlatuzumab
High Dose Cytarabine
antibody
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs