Refractory Acute Myeloid LeukemiaPhase 1/2NCT04956042
Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing Fosciclopirox and Fosciclopirox + Cytarabine in people with Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, run by CicloMed LLC at 2 sites in United States.
Trial summary
This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, pharmacokinetics, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML with up to two cohorts studied to confirm the efficacy (or futility) of fosciclopirox on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia
- What is being tested?
- Fosciclopirox and Fosciclopirox + Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2021to 31 Dec 2023
- Phase
- Phase 1/2
- 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
- Patient is male or female aged ≥18 years.
- Patient provided signed and dated informed consent prior to initiation of any study procedures.
- Patient has relapsed AML after complete remission of any duration as evidenced by presence of neoplastic blasts in the bone marrow confirmed by flow cytometry OR has refractory AML, defined as primary refractory to at least 2 cycles of induction therapy.
- No other therapy exists or patient has received all standard therapies that would be potentially curative or might provide significant benefit.
- Patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2.
- Patient has a predicted life expectancy of ≥3 months.
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- Patient has a total white blood cell count of count ≤ 25.0 x 10^9/L at screening and on C1D1. (Patient may have received hydroxyurea prior to the screening sample for elevated WBC but must have discontinued the therapy at least 72 hours prior to screening, and not be treated with hydroxyurea after the screening sample has been taken).
- Patient has adequate renal function (creatinine ≤2 × the upper limit of the normal range (ULN) and an estimated glomerular filtration rate (eGFR) of >30 mL/min/1.73 m^2).
- Patient has adequate hepatic function, as evidenced by a total bilirubin ≤2 × ULN, aspartate aminotransferase (AST) ≤5 × ULN and /or alanine aminotransferase (ALT)
- ≤5 × ULN, unless due to leukemia involvement in the judgement of the Principal Investigator in consultation with the Medical Monitor.
- Patient has adequate cardiac function with an ejection fraction (EF) ≥45%, as assessed by multi-gated acquisition (MUGA) or ultrasound/echocardiography (ECHO) and corrected QT interval by Fridericia's correction formula (QTcF) <450 msec for males and <470 msec for females. The eligibility of patients with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the Sponsor in consultation with the Medical Monitor.
- Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of fosciclopirox, as follows:
- For women: Negative pregnancy test during Screening and at Day 1 of each treatment cycle and compliant with a medically-approved contraceptive regimen during, and for 3 months after, the Treatment period or documented to be surgically sterile or postmenopausal.
- For men: Compliant with a medically-approved contraceptive regimen during, and for 3 months after, the Treatment period or documented to be surgically sterile. Men whose sexual partners are of child-bearing potential must agree to use 2 methods of contraception prior to study entry, during the study, and for 3 months after the Treatment period. Men must also agree not to donate sperm during the Treatment period and for 3 months after the Treatment period.
- Patient is willing and able to participate in the study and comply with all study requirements.
- Prior allogeneic stem cell transplant is allowed as long as patient is more than 100 days post-transplant and has no active graft versus host disease.
Who cannot join
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- Patient has another active malignancy.
- Patient has acute promyelocytic leukemia (APL) or Ph+ AML.
- Patient has total white blood cell count >25.0 x 10^9/L at C1D1.
- Patient has clinically significant cardiac disease.
- Patient has known chronic active liver disease or evidence of acute or chronic Hepatitis B Virus (HBV) or Hepatitis C (HCV).
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- Patient has known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required in absence of clinical suspicion.
- Patients has any serious and/or uncontrolled concurrent medical conditions (e.g., uncontrolled infection, uncontrolled diabetes) or psychiatric illness that could, in the investigator's opinion, cause unacceptable safety risks or potentially interfere with the completion of the treatment according to the protocol.
- Patient has received any live viral vaccine used for prevention of infectious diseases within 4 weeks prior to Baseline.
- If female, patient is pregnant or breast-feeding.
- Patient is taking warfarin.
- Patient has known allergy or hypersensitivity to any component of fosciclopirox.
- Patient is taking any iron replacement therapy administered IV, intramuscularly, or orally due to the potential for loss of anticancer activity due to drug and/or metabolites chelating iron.
- Patient is taking Hydrea (hydroxyurea) within 72 hours prior to the screening visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Hopkins School of Medicine
Baltimore, Maryland, 21287
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Phase 1B/2A, Open-label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Fosciclopirox Alone and In Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, pharmacokinetics, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML with up to two cohorts studied to confirm the efficacy (or futility) of fosciclopirox on the endpoint of disease response.
Initially, 14 evaluable patients will be enrolled in Cohort 1a. If disease response to fosciclopirox alone IS observed in at least 4 of 14 patients, an additional 14 patients will be enrolled in Cohort 1b. If disease response to fosciclopirox alone IS NOT observed in at least 4 of 14 patients in Cohort 1a, based on a review of all available study data, the study may be terminated OR a Cohort 2a may be initiated using the combination of fosciclopirox and cytarabine. If disease response to fosciclopirox in combination with cytarabine IS observed in at least 4 of 14 patients in Cohort 2a, an additional 14 patients will be enrolled in Cohort 2b. If disease response to fosciclopirox in combination with cytarabine IS NOT observed in at least 4 of 14 patients in the Cohort 2a, the study will be stopped for futility.
Read the detailed description
This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, PK, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML. There will be up to two cohorts used to confirm the efficacy (or futility) of fosciclopirox on the endpoint of disease response.
Initially, 14 patients will be enrolled in Cohort 1a. If disease response to fosciclopirox alone IS observed in at least 4 of 14 patients, an additional 14 patients will be enrolled in Cohort 1b. If disease response to fosciclopirox alone IS NOT observed in at least 4 of 14 patients in the initial Cohort 1a, based on a review of all available data study data, the study may be terminated OR a second cohort (Cohort 2a) may be initiated using the combination of fosciclopirox and cytarabine. If disease response to fosciclopirox in combination with cytarabine IS observed in at least 4 of 14 patients in Cohort 2a, an additional 14 patients will be enrolled in Cohort 2b. If disease response to fosciclopirox in combination with cytarabine IS NOT observed in at least 4 of 14 patients in Cohort 2a, the study will be stopped for futility.
If both Cohorts 1a and 2a are initiated, the minimum patient number will be 28 (i.e., treatment with fosciclopirox alone and in combination with cytarabine are futile). The maximum number of patients potentially evaluated is 42 (i.e., the first treatment is futile based upon observations in 14 patients (Cohort 1a), but treatment in Cohort 2a evaluated is positive [14 patients], and Cohort 2b [14 patients] is completed).
Patients in Cohort 1a will initially be treated with fosciclopirox as a single agent. Patients who respond to this treatment, as defined below, may continue to receive treatment cycles of fosciclopirox alone until evidence of disease progression. Patients who do not respond to fosciclopirox alone, as defined below, may be switched to treatment with the combination of fosciclopirox and cytarabine. Patients who respond to the combination treatment may continue to receive treatment cycles of fosciclopirox in combination with cytarabine until evidence of disease progression. Patients who do not respond to the combination of fosciclopirox and cytarabine will be discontinued from the study.
Patients enrolled in Cohort 2a (if initiated) will initially be treated with fosciclopirox in combination with cytarabine. The first patient to receive this combination will be observed during Cycle 1 (21 days) and for a further 7 days (if they do not continue to Cycle 2) before any further patients are accrued to the combination arm. As above, patients who respond to the combination treatment may continue to receive treatment cycles until evidence of disease progression, and patients who do not respond will be discontinued from the study.
Fosciclopirox will be administered as 900 mg/m2 once daily as a 20-minute intravenous infusion on Days 1 to 5 (D1-D5) of each 21-day treatment cycle (rest days D6-D21). When added to fosciclopirox therapy, cytarabine will be administered as 1 gm/m2 once daily on D1 D5 of each 21-day treatment cycle (rest days D6-D21).
- Being tested
- Fosciclopirox, Fosciclopirox + 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.
FosciclopiroxDrug
Fosciclopirox, 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle
Fosciclopirox + CytarabineDrug
Fosciclopirox - 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle
Cytarabine - 1g/m2 once daily on D1-D5 of each 21-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Fosciclopirox only | Experimental | An initial 14 study participants will be enrolled in Cohort 1a and will be treated with fosciclopirox. If there is a disease response, an additional 14 study participants will be enrolled into Cohort 1 (Cohort 1b). Receives: Drug: Fosciclopirox |
| Cohort 2 - Fosciclopirox + Cytarabine | Experimental | To be implemented if a disease response is not seen in Cohort 1a. Cohort 2a will have an initial 14 study participants treated with fosciclopirox and cytarabine. If a disease response is seen, an additional 14 study participants will be enrolled (Cohort 2b). Receives: Drug: Fosciclopirox + Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Myeloid Leukemia (AML) response
Complete remission [CR], CR with incomplete hematologic recovery [CRi], partial remission [PR], or morphologic leukemia-free state [MLFS] at the conclusion of the first treatment cycle OR Nonprogression at the end of the first treatment cycle (defined as no increase in bone marrow or peripheral blood blast count) followed by CR, CRi, PR, or MLFS at the conclusion of the second treatment cycle
Measured: Screening through Day 42
Frequency and type of treatment-related AEs
Adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From Informed Consent Form through Follow Up visit (30±5 days after last dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start27 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CicloMed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956042
- Sponsor's protocol ID
- CPX-POM-003
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B/2A, Open-label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Fosciclopirox Alone and In Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT04956042
- Acronym / sponsor ID
- CPX-POM-003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CicloMed LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jul 2021 (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 will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, pharmacokinetics, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML with up to two cohorts studied to confirm the efficacy (or futility) of fosciclopirox on the endpoint of disease response.
Initially, 14 evaluable patients will be enrolled in Cohort 1a. If disease response to fosciclopirox alone IS observed in at least 4 of 14 patients, an additional 14 patients will be enrolled in Cohort 1b. If disease response to fosciclopirox alone IS NOT observed in at least 4 of 14 patients in Cohort 1a, based on a review of all available study data, the study may be terminated OR a Cohort 2a may be initiated using the combination of fosciclopirox and cytarabine. If disease response to fosciclopirox in combination with cytarabine IS observed in at least 4 of 14 patients in Cohort 2a, an additional 14 patients will be enrolled in Cohort 2b. If disease response to fosciclopirox in combination with cytarabine IS NOT observed in at least 4 of 14 patients in the Cohort 2a, the study will be stopped for futility.
Detailed description
This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, PK, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML. There will be up to two cohorts used to confirm the efficacy (or futility) of fosciclopirox on the endpoint of disease response.
Initially, 14 patients will be enrolled in Cohort 1a. If disease response to fosciclopirox alone IS observed in at least 4 of 14 patients, an additional 14 patients will be enrolled in Cohort 1b. If disease response to fosciclopirox alone IS NOT observed in at least 4 of 14 patients in the initial Cohort 1a, based on a review of all available data study data, the study may be terminated OR a second cohort (Cohort 2a) may be initiated using the combination of fosciclopirox and cytarabine. If disease response to fosciclopirox in combination with cytarabine IS observed in at least 4 of 14 patients in Cohort 2a, an additional 14 patients will be enrolled in Cohort 2b. If disease response to fosciclopirox in combination with cytarabine IS NOT observed in at least 4 of 14 patients in Cohort 2a, the study will be stopped for futility.
If both Cohorts 1a and 2a are initiated, the minimum patient number will be 28 (i.e., treatment with fosciclopirox alone and in combination with cytarabine are futile). The maximum number of patients potentially evaluated is 42 (i.e., the first treatment is futile based upon observations in 14 patients (Cohort 1a), but treatment in Cohort 2a evaluated is positive [14 patients], and Cohort 2b [14 patients] is completed).
Patients in Cohort 1a will initially be treated with fosciclopirox as a single agent. Patients who respond to this treatment, as defined below, may continue to receive treatment cycles of fosciclopirox alone until evidence of disease progression. Patients who do not respond to fosciclopirox alone, as defined below, may be switched to treatment with the combination of fosciclopirox and cytarabine. Patients who respond to the combination treatment may continue to receive treatment cycles of fosciclopirox in combination with cytarabine until evidence of disease progression. Patients who do not respond to the combination of fosciclopirox and cytarabine will be discontinued from the study.
Patients enrolled in Cohort 2a (if initiated) will initially be treated with fosciclopirox in combination with cytarabine. The first patient to receive this combination will be observed during Cycle 1 (21 days) and for a further 7 days (if they do not continue to Cycle 2) before any further patients are accrued to the combination arm. As above, patients who respond to the combination treatment may continue to receive treatment cycles until evidence of disease progression, and patients who do not respond will be discontinued from the study.
Fosciclopirox will be administered as 900 mg/m2 once daily as a 20-minute intravenous infusion on Days 1 to 5 (D1-D5) of each 21-day treatment cycle (rest days D6-D21). When added to fosciclopirox therapy, cytarabine will be administered as 1 gm/m2 once daily on D1 D5 of each 21-day treatment cycle (rest days D6-D21).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Fosciclopirox only | Experimental | Drug: FosciclopiroxAn initial 14 study participants will be enrolled in Cohort 1a and will be treated with fosciclopirox. If there is a disease response, an additional 14 study participants will be enrolled into Cohort 1 (Cohort 1b). |
| Cohort 2 - Fosciclopirox + Cytarabine | Experimental | Drug: Fosciclopirox + CytarabineTo be implemented if a disease response is not seen in Cohort 1a. Cohort 2a will have an initial 14 study participants treated with fosciclopirox and cytarabine. If a disease response is seen, an additional 14 study participants will be enrolled (Cohort 2b). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient is male or female aged ≥18 years.
- Patient provided signed and dated informed consent prior to initiation of any study procedures.
- Patient has relapsed AML after complete remission of any duration as evidenced by presence of neoplastic blasts in the bone marrow confirmed by flow cytometry OR has refractory AML, defined as primary refractory to at least 2 cycles of induction therapy.
- No other therapy exists or patient has received all standard therapies that would be potentially curative or might provide significant benefit.
- Patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, or 2.
Key exclusion criteria (14 listed)
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- Patient has another active malignancy.
- Patient has acute promyelocytic leukemia (APL) or Ph+ AML.
- Patient has total white blood cell count >25.0 x 10^9/L at C1D1.
- Patient has clinically significant cardiac disease.
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 |
|---|---|---|
| FosciclopiroxFosciclopirox, 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle | Drug | Cohort 1 - Fosciclopirox only |
| Fosciclopirox + CytarabineFosciclopirox - 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle Cytarabine - 1g/m2 once daily on D1-D5 of each 21-day treatment cycle | Drug | Cohort 2 - Fosciclopirox + Cytarabine |
Primary outcome
Acute Myeloid Leukemia (AML) response
Time frame: Screening through Day 42
Complete remission [CR], CR with incomplete hematologic recovery [CRi], partial remission [PR], or morphologic leukemia-free state [MLFS] at the conclusion of the first treatment cycle OR Nonprogression at the end of the first treatment cycle (defined as no increase in bone marrow or peripheral blood blast count) followed by CR, CRi, PR, or MLFS at the conclusion of the second treatment cycle
Frequency and type of treatment-related AEs
Time frame: From Informed Consent Form through Follow Up visit (30±5 days after last dose of study drug)
Adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Results and safety
The study was stopped early (reason given: Discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fosciclopirox and Fosciclopirox + Cytarabine in people with Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, run by CicloMed LLC at 2 sites 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 16 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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 stopped early (reason given: Discontinued). 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?
Acute Myeloid Leukemia (AML) response (time frame: Screening through Day 42). 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?
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 12 Feb 2024.