Lymphoproliferative MalignanciesPhase 1NCT02238522
Phase 1 Study Evaluating ZEN003365 in Relapsed/Refractory Lymphoproliferative Malignancies or Relapsed/Refractory AML
A Phase 1 study testing ZEN003365 in people with Lymphoproliferative Malignancies and Acute Myeloid Leukemia, run by Zenith Epigenetics at 4 sites in United States.
Trial summary
The purpose of this study is to determine safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoproliferative Malignancies, Acute Myeloid Leukemia
- What is being tested?
- ZEN003365
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Jan 2017
- 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
- Dose Escalation and Expansion Stages:
- ECOG performance status ≤ 1 for LPM patients, ≤ 2 for AML patients
- Age 18 years or older
- Adverse events (AEs), except for alopecia, from any previous treatments must have recovered to eligibility levels from prior toxicity
- Adequate renal, hepatic and coagulation function, as specified per protocol
- Written informed consent granted prior to any study-specific screening procedures
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- LPM Patients:
- Histologically confirmed lymphoproliferative malignancy
- Have received prior protocol-specified disease-dependent prior treatments
- Have measurable disease
- Platelets ≥ 75,000/µL (≥50,000/µL if bone marrow involvement), absolute neutrophil count (ANC) ≥ 1,000/ µL, and hemoglobin (Hgb) ≥ 8 g/dL
- Patients must have been off previous anticancer therapy for at least 3 weeks or 5 half-lives, whichever is longer, and the subject must have recovered to eligibility levels from prior toxicity
- AML:
- Refractory or relapsed AML patients, without curative intent, e.g., not a stem cell transplant candidate
- Any prior chemotherapy must have been completed ≥ 2 weeks, any therapy with biologics must have been completed ≥ 4 weeks prior to day 1 of study treatment, and the participant must have recovered to eligibility levels from prior toxicity
- Blast count ≤ 10,000/µL prior to initiation of therapy
Who cannot join
- Dose Escalation and Expansion Stages:
- Prior exposure to a BET inhibitor
- Prior allogeneic hematopoietic cell transplant
- Chronic graft versus host disease
- Known, active fungal, bacterial, and/or viral infection
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
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- Current subdural hematoma
- CNS or leptomeningeal metastases
- Requirement for medications or agents known to be sensitive CYP3A4 substrate drugs, CYP3A4 substrate drugs with a narrow therapeutic range or to be strong inhibitors/inducers of CYP3A4
- Requirement for immunosuppressive agents
- Evidence of significant cardiovascular disease or significant screening ECG abnormalities
- Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.
- AML patients:
- Acute promyelocytic leukemia (APL)
- Chronic myeloid leukemia (CML) in blast crisis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase 1 Open-label Dose Escalation and Expansion Study of ZEN003365 in Subjects With Relapsed or Refractory Lymphoproliferative Malignancies or Acute Myeloid Leukemia
The purpose of this study is to determine safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).
- Being tested
- ZEN003365
- Keywords
- Chronic lymphocytic leukemia, B-prolymphocytic leukemia, Non-Hodgkin's lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, diffuse large B-cell lymphoma, unclassifiable lymphoma, T-cell lymphoma, Richter's syndrome, Waldenström's macroglobulinemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEN003365Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Stage - ZEN003365 | Experimental | ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients Receives: Drug: ZEN003365 |
| Dose Expansion Stage - ZEN003365 | Experimental | ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients Receives: Drug: ZEN003365 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation stage - The safety of orally administered ZEN003365, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Measured: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose escalation stage - To characterize the DLTs of orally administered ZEN003365, using NCI CTCAE v4.03
Measured: The first 25 days of at least 12 doses of ZEN003365
Dose expansion stage - Preliminary evidence of the antitumor activity of orally administered ZEN003365 in selected patients, assessed by objective response, duration of objective response and progression-free survival
Measured: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - The safety of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Measured: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Secondary outcomes (2)
Dose escalation stage - To characterize the pharmacokinetics (PK) of orally administered ZEN003365 in patients, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio
Measured: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - To characterize the PK of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio
Measured: From Screening Visit through 40 days after the last day of treatment with ZEN003365 (19 weeks, average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoproliferative MalignanciesStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zenith Epigenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238522
- Sponsor's protocol ID
- ZEN-ONC3365-101
- Status last verified
- Nov 2014
- First submitted
- 28 Aug 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-label Dose Escalation and Expansion Study of ZEN003365 in Subjects With Relapsed or Refractory Lymphoproliferative Malignancies or Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02238522
- Acronym / sponsor ID
- ZEN-ONC3365-101
- Keywords
- Chronic lymphocytic leukemia, B-prolymphocytic leukemia, Non-Hodgkin's lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, diffuse large B-cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zenith EpigeneticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- 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.
The purpose of this study is to determine safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Stage - ZEN003365 | Experimental | Drug: ZEN003365ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients |
| Dose Expansion Stage - ZEN003365 | Experimental | Drug: ZEN003365ZEN003365 will be administered orally as a single agent, enrolling LPM patients and AML patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- ECOG performance status ≤ 1 for LPM patients, ≤ 2 for AML patients
- Age 18 years or older
- Adverse events (AEs), except for alopecia, from any previous treatments must have recovered to eligibility levels from prior toxicity
- Adequate renal, hepatic and coagulation function, as specified per protocol
- Written informed consent granted prior to any study-specific screening procedures
Key exclusion criteria (15 listed)
- Prior exposure to a BET inhibitor
- Prior allogeneic hematopoietic cell transplant
- Chronic graft versus host disease
- Known, active fungal, bacterial, and/or viral infection
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
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 |
|---|---|---|
| ZEN003365 | Drug | Dose Escalation Stage - ZEN003365, Dose Expansion Stage - ZEN003365 |
Primary outcome
Dose escalation stage - The safety of orally administered ZEN003365, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose escalation stage - To characterize the DLTs of orally administered ZEN003365, using NCI CTCAE v4.03
Time frame: The first 25 days of at least 12 doses of ZEN003365
Dose expansion stage - Preliminary evidence of the antitumor activity of orally administered ZEN003365 in selected patients, assessed by objective response, duration of objective response and progression-free survival
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - The safety of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
2 secondary outcomes
Dose escalation stage - To characterize the pharmacokinetics (PK) of orally administered ZEN003365 in patients, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - To characterize the PK of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio
Time frame: From Screening Visit through 40 days after the last day of treatment with ZEN003365 (19 weeks, average)
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 13 Nov 2014.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZEN003365 in people with Lymphoproliferative Malignancies and Acute Myeloid Leukemia, run by Zenith Epigenetics at 4 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 15 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 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?
Dose escalation stage - The safety of orally administered ZEN003365, assessed by frequency of adverse events, including worsening of medical conditions/diseases (time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)). The study lists 4 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 13 Nov 2014.