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AzTrials

Recurrent Acute Myeloid LeukemiaPhase 1NCT03752138

TK216 and Decitabine in Treating Patients With Relapsed and Refractory Acute Myeloid Leukemia

A Phase 1 study testing Group 1: TK216, Group 2: TK216 and Part 2: Decitabine 10mg/m2 in people with Recurrent Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of TK216 and decitabine when given together in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Group 1: TK216, Group 2: TK216 and Part 2: Decitabine 10mg/m2
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 Mar 2019to 31 Dec 2020
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

  • Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia for which no available standard therapies are indicated or anticipated to result in a durable response
  • Patients must not have had leukemia therapy for 14 days prior to starting TK216. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study
  • Bilirubin =< 2 mg/dL
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) -- or =< 5 x ULN if related to leukemic involvement
  • Creatinine =< 1.5 x ULN
  • Known cardiac ejection fraction of > or = 45% within the past 3 months
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  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
  • Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol

Who cannot join

  • Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided
  • Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient with documented hypersensitivity to any of the components of the therapy program
  • Patients with active, uncontrolled central nervous system (CNS) leukemia will not be eligible
  • Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use at least 1 form of barrier birth control (such as condom) prior to study entry and for the duration of study participation
  • Patients with known history of serous retinopathy will not be eligible
  • Prior treatment with TK216

About this study

Official title: Phase I Study of TK216 in Patients With Relapsed and Refractory Leukemias

This phase I trial studies the side effects and best dose of TK216 and decitabine when given together in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as TK216 and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of Ets-family transcription factor inhibitor TK216 (TK216) in patients with relapsed and refractory (R/R) acute myeloid leukemia (AML). (Phase I Dose Escalation) II. To determine the safety and tolerability of TK216 combined with decitabine in patients with relapsed and refractory AML. (Combination Cohort)

SECONDARY OBJECTIVES:

  1. Safety profile of TK216 as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Phase I Dose Escalation) II. To explore the efficacy (complete remission [CR], complete remission without platelet recovery [CRp], complete remission without blood count recovery [CRi], or partial remission [PR]), of TK216 as a single-agent in patients with R/R AML. (Phase I Dose Escalation) III. To assess overall survival (OS), and disease free survival (DFS) in patients with R/R AML treated with TK216. (Phase I Dose Escalation) IV. Duration of disease control defined as first date of disease control identified (either CR/CRp/CRi, PR or SD) until the date of progression. (Phase I Dose Escalation) V. To explore biomarkers of response and resistance in patients with R/R AML treated with TK216. (Phase I Dose Escalation) VI. Safety profile of TK216 in combination with decitabine as characterized by adverse event (AE) type, severity, timing and relationship to study drug, as well as laboratory abnormalities in the first and subsequent treatment cycles. (Combination Cohort) VII. To explore the efficacy (complete remission [CR], complete remission without platelet recovery [CRp], complete remission without blood count recovery [CRi], or partial remission [PR], of TK216 in combination with decitabine in patients with R/R AML. (Combination Cohort) VIII. To assess overall survival (OS), and progression free survival (PFS) in patients with R/R AML treated with TK216 + decitabine. (Combination Cohort) IX. Duration of disease control defined as first date of disease control identified (either CR/CRp/CRi, PR or SD) until the date of progression. (Combination Cohort) X. To explore biomarkers of response and resistance in patients with R/R AML treated with TK216 + decitabine. (Combination Cohort)

OUTLINE: This is a dose-escalation study.

Patients receive TK216 intravenously (IV) continuously on days 1-7 every 21 days, or continuously on days 1-7 and 15-21 every 28 days. Patients also receive decitabine IV over 60 minutes on days 1-10 every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Being tested
Group 1: TK216, Group 2: TK216, Part 2: Decitabine 10mg/m2, Part 2: Decitabine 20 mg/m2, Expansion Phase TK216
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.

  • Group 1: TK216Drug

    Starting Dose: 288 mg/m2 given by vein on Days 1-7 of a 21 day cycle.

  • Group 2: TK216Drug

    Also called TK-216, TK216

    Starting Dose: 144 mg/m2 given by vein on Days 1-7 and 15-21 of a 23 day cycle.

  • Part 2: Decitabine 10mg/m2Drug

    Also called Dacogen

    10mg/m2 by vein on Days 1-10 of a 28 day cycle.

  • Part 2: Decitabine 20 mg/m2Drug

    Also called Dacogen

    20 mg/m2 by vein on Days 1-10 of a 28 dayi cycle.

  • Expansion Phase TK216Drug

    Expansion cohort will receive the RP2D of TK216

  • Expansion Phase DecitabineDrug

    Also called Dacogen

    Expansion cohort will receive the RP2D of Decitabine

  • Part 2: TK216Drug

    Recommended dose from Part 1.

Study groups in NCT03752138
Study groupRoleWhat they receive
Group 1 Part 1 TK216: Days 1-7ExperimentalPatients receive TK216 IV continuously on days 1-7 every 21 days.
Receives: Drug: Group 1: TK216
Group 2 Part 1 TK216: Days 1-7 and 15-28ExperimentalPatients receive TK216 IV on days 1-7 and 15-21 every 28 days.
Receives: Drug: Group 2: TK216
Part 2 TK216 + Decitabine 10mg/m2ExperimentalPatients receive recommended dose of TK216 from Part 1 plus Decitabine.
Receives: Drug: Part 2: Decitabine 10mg/m2; Drug: Part 2: TK216
Part 2 TK216 + Decitabine 20 mg/m2ExperimentalPatients receive recommended dose of TK216 from Part 1 plus Decitabine.
Receives: Drug: Part 2: Decitabine 20 mg/m2; Drug: Part 2: TK216
Expansion Phase: TK216 + DecitabineExperimentalAll patients in the expansion cohort will receive the RP2D of TK216 and Decitabine.
Receives: Drug: Expansion Phase TK216; Drug: Expansion Phase Decitabine

What is being measured

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

  1. Incidence of adverse events

    Will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.

    Measured: Up to 30 days

  2. Response rate

    Will be estimated alone with 95% confidence interval.

    Measured: Up to 30 days

  3. Overall survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  4. Disease free survival

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  5. Duration of disease control

    Will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

Timeline

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

  1. First posted23 Nov 2018
  2. Study start31 Mar 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Why it stopped: The supporting pharamceutical company elected not to pursue this study at this time.

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03752138
Sponsor's protocol ID
2018-0495
Other IDs
NCI-2018-02667, 2018-0495, P30CA016672
Status last verified
May 2019
First submitted
20 Nov 2018
Last updated
6 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Group 1: TK216, Group 2: TK216 and Part 2: Decitabine 10mg/m2 in people with Recurrent Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by M.D. Anderson Cancer Center.

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 9 inclusion and 7 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 6 May 2019. 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 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?

Incidence of adverse events (time frame: Up to 30 days). The study lists 5 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 NCT03752138.

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 6 May 2019.

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