Acute Myeloid LeukemiaPhase 2CyFi2NCT04100330
A Study of Ficlatuzumab With HiDAC and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 2 study testing Ficlatuzumab and Cytarabine in people with Acute Myeloid Leukemia, run by AVEO Pharmaceuticals, Inc..
Trial summary
This is a Phase 2, randomized, open-label, multicenter study to evaluate the safety and efficacy of ficlatuzumab in combination with high-dose cytarabine (HiDAC) and HiDAC alone in subjects with relapsed or refractory acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2020to 27 Mar 2020
- Phase
- Phase 2
- 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
- Diagnosis of AML according to the WHO criteria, which defines relapsed or refractory to induction therapy as follows:
- First relapse within 12 months after date of first CR or CRi
- Persistent AML documented by bone marrow biopsy at least 29 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 the first induction cycle Day 1
- Age ≥18 years
- Prior induction therapy, consisting of no more than 2 cycles of cytotoxic chemotherapy with at least one of the cycles consisting of anthracycline and cytarabine with reasonable schedule/dose intensity according to the discretion of the Investigator
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- Histologically confirmed AML by hematopathology review performed within 4 weeks of study entry. Secondary AML due to progression of myelodysplastic syndrome or myeloproliferative neoplasms is acceptable for inclusion.
- Prior treatment for myelodysplastic syndrome or myeloproliferative neoplasm with hypomethylating agent or targeted agent is acceptable for inclusion
- Ejection fraction ≥40% by echocardiogram or multigated acquisition (MUGA) scan
- Cytoreduction therapy with leukapheresis or hydroxyurea is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Clinical laboratory values meeting the following criteria before Day 1 (Cycle 1, Day 1):
- An estimated glomerular filtration rate of ≥ 60mL/min based on Cockcroft-Gault equation calculated using serum creatinine levels
- Total bilirubin ≤2.0 mg/dL (≤3.0 mg/dL for subjects with known Gilbert's syndrome)
- Aspartate aminotransferase (AST) or ALT ≤2.5 × ULN, unless thought to be due to AML
- Activated partial thromboplastin time ≤1.5 × ULN and prothrombin time/international normalized ratio (PT/INR) ≤1.5 × ULN if not on anticoagulation therapy. Subjects receiving anticoagulation therapy with an agent such as warfarin or low-molecular weight heparin may be allowed to participate with the therapeutic range established before initiation of study treatment.
- For female subjects of childbearing potential, documentation of negative serum pregnancy test before randomization
- For female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential, agreement to use an effective method of contraception during the study and for at least 90 days after the last dose of ficlatuzumab. Effective birth control includes (a) intrauterine device plus 1 barrier method; (b) oral, implantable, or injectable contraceptive plus 1 barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
- Ability to give written informed consent and comply with protocol requirements
Who cannot join
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cytarabine
- Acute promyelocytic leukemia (AML French-American-British classification M3)
- More than 2 cycles of prior induction therapy for AML
- Prior treatment with intermediate- or HiDAC (≥1 gm/m2)
- Allogeneic or autologous hematopoietic cell transplantation within 90 days of study entry
- Prior treatment with any other investigational drugs, biologics, or devices, within 4 weeks before Day 1
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- Active graft versus host disease or immunosuppression for prevention or treatment of graft versus host disease within 4 weeks of study entry
- Chemotherapy or radiation therapy within 1 week before study entry, other than hypomethylating agents or hydroxyurea used for cytoreduction
- Significant cardiovascular disease, including:
- Cardiac failure New York Heart Association class III or IV
- Myocardial infarction, severe or unstable angina within 6 months before Day 1
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation)
- Significant thrombotic or embolic events within 3 months before Day 1 (significant thrombotic or embolic events include, but are not limited to, venous thromboembolism, stroke, or transient ischemic attack). Catheter-related thrombosis is not a cause for exclusion. Diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred >3 months before Day 1 and anticoagulation therapy is completed before Day 1.
- Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results
- History of prior/concurrent malignancy whose natural history or ongoing treatment is expected to interfere with the safety or efficacy assessment of the intervention
- Known seropositive or active HIV
- Active hepatitis B or C infection
- Uncontrolled systemic fungal, bacterial, or viral infections
- For female subjects, pregnant or breastfeeding
- Prior exposure to the investigational agent or anti-c-MET, or anti-HGF within 6 months before study entry
About this study
Official title: A Phase 2, Randomized, Open-Label, Multicenter Study of Ficlatuzumab in Combination With High-Dose Cytarabine (HiDAC) and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 2, randomized, open-label, multicenter study to evaluate the safety and efficacy of ficlatuzumab in combination with high-dose cytarabine (HiDAC) and HiDAC alone in subjects with relapsed or refractory acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Ficlatuzumab, Cytarabine
- 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.
FiclatuzumabBiological
Also called AV-299
Ficlatuzumab is a selective recombinant humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G subclass 1 monoclonal antibody which blocks the MET tyrosine kinase receptor.
CytarabineDrug
Also called Ara-C, Arabinosylcytosine
Cytarabine is a chemotherapy agent. Chemotherapy agents are medications that kill cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Ficlatuzumab with HiDAC | Experimental | Ficlatuzumab 20 mg/kg intravenously (IV) on Days 1 and 15 in combination with cytarabine 2 g/m2 IV per day on Days 2 through 7. Up to two additional doses can be administered - on Day 29, or on Days 29 and 43, if prolonged myelosuppression is experienced. Receives: Biological: Ficlatuzumab; Drug: Cytarabine |
| HiDAC alone | Active comparator | Cytarabine 2 g/m2 IV per day on Days 1 through 6 Receives: Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
To estimate the overall response rate (ORR) (complete remission [CR] + CR with incomplete hematologic recovery [CRi]) of ficlatuzumab in combination with high-dose cytarabine (HiDAC) and HiDAC alone in adults with relapsed or refractory acute myeloid leukemia (AML)
Measured: Approximately 13 months (through study treatment completion)
Secondary outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the safety and tolerability of ficlatuzumab when administered with HiDAC and HiDAC alone
Measured: Approximately 14 months (through 30 days after the last subject completes treatment)
Overall Survival (OS)
To estimate the overall survival (OS) rate of ficlatuzumab in combination with HiDAC and HiDAC alone in adults with relapsed or refractory AML
Measured: For up to one year after the end of study treatment
Disease-Free Survival (DFS)
To estimate the disease-free survival (DFS) rate of ficlatuzumab in combination with HiDAC and HiDAC alone in subjects achieving CR
Measured: For up to one year after the end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start31 Jan 2020 (estimated)
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Why it stopped: Urgent shift among clinical sites toward efforts to combat COVID-19 pandemic;impacted feasibility of completing study within shelf-life of current IP supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biodesix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100330
- Sponsor's protocol ID
- AV-299-19-207
- Acronym
- CyFi2
- Status last verified
- Mar 2020
- First submitted
- 12 Sep 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Multicenter Study of Ficlatuzumab in Combination With High-Dose Cytarabine (HiDAC) and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT04100330
- Acronym / sponsor ID
- CyFi2 / AV-299-19-207
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Urgent shift among clinical sites toward efforts to combat COVID-19 pandemic;impacted feasibility of completing study within shelf-life of current IP supply
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biodesix, Inc.
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, open-label, multicenter study to evaluate the safety and efficacy of ficlatuzumab in combination with high-dose cytarabine (HiDAC) and HiDAC alone in subjects with relapsed or refractory acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ficlatuzumab with HiDAC | Experimental | Biological: Ficlatuzumab, Drug: CytarabineFiclatuzumab 20 mg/kg intravenously (IV) on Days 1 and 15 in combination with cytarabine 2 g/m2 IV per day on Days 2 through 7. Up to two additional doses can be administered - on Day 29, or on Days 29 and 43, if prolonged myelosuppression is experienced. |
| HiDAC alone | Active comparator | Drug: CytarabineCytarabine 2 g/m2 IV per day on Days 1 through 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of AML according to the WHO criteria, which defines relapsed or refractory to induction therapy as follows:
- Age ≥18 years
- Prior induction therapy, consisting of no more than 2 cycles of cytotoxic chemotherapy with at least one of the cycles consisting of anthracycline and cytarabine with reasonable schedule/dose intensity according to the discretion of the Investigator
- Histologically confirmed AML by hematopathology review performed within 4 weeks of study entry. Secondary AML due to progression of myelodysplastic syndrome or myeloproliferative neoplasms is acceptable for inclusion.
- Prior treatment for myelodysplastic syndrome or myeloproliferative neoplasm with hypomethylating agent or targeted agent is acceptable for inclusion
Key exclusion criteria (20 listed)
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or cytarabine
- Acute promyelocytic leukemia (AML French-American-British classification M3)
- More than 2 cycles of prior induction therapy for AML
- Prior treatment with intermediate- or HiDAC (≥1 gm/m2)
- Allogeneic or autologous hematopoietic cell transplantation within 90 days of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiclatuzumabAlso: AV-299Ficlatuzumab is a selective recombinant humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G subclass 1 monoclonal antibody which blocks the MET tyrosine kinase receptor. | Biological | Ficlatuzumab with HiDAC |
| CytarabineAlso: Ara-C, ArabinosylcytosineCytarabine is a chemotherapy agent. Chemotherapy agents are medications that kill cancer cells. | Drug | Ficlatuzumab with HiDAC, HiDAC alone |
Primary outcome
Overall Response Rate (ORR)
Time frame: Approximately 13 months (through study treatment completion)
To estimate the overall response rate (ORR) (complete remission [CR] + CR with incomplete hematologic recovery [CRi]) of ficlatuzumab in combination with high-dose cytarabine (HiDAC) and HiDAC alone in adults with relapsed or refractory acute myeloid leukemia (AML)
3 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Approximately 14 months (through 30 days after the last subject completes treatment)
Overall Survival (OS)
Time frame: For up to one year after the end of study treatment
Disease-Free Survival (DFS)
Time frame: For up to one year after the end of study treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ficlatuzumab and Cytarabine in people with Acute Myeloid Leukemia, run by AVEO Pharmaceuticals, Inc..
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 19 inclusion and 20 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: withdrawn, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Overall Response Rate (ORR) (time frame: Approximately 13 months (through study treatment completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2020.