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

2 maggio 2019 aggiornato da: M.D. Anderson Cancer Center

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.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Tipo di studio

Interventistico

Fase

  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1 Part 1 TK216: Days 1-7
Patients receive TK216 IV continuously on days 1-7 every 21 days.
Droga: Group 1: TK216
Starting Dose: 288 mg/m2 given by vein on Days 1-7 of a 21 day cycle.
Sperimentale: Group 2 Part 1 TK216: Days 1-7 and 15-28
Patients receive TK216 IV on days 1-7 and 15-21 every 28 days.
Droga: Group 2: TK216
Starting Dose: 144 mg/m2 given by vein on Days 1-7 and 15-21 of a 23 day cycle.
Altri nomi:
  • TK-216
  • TK216
Sperimentale: Part 2 TK216 + Decitabine 10mg/m2
Patients receive recommended dose of TK216 from Part 1 plus Decitabine.
Droga: Part 2: Decitabine 10mg/m2
10mg/m2 by vein on Days 1-10 of a 28 day cycle.
Altri nomi:
  • Dacogeno
Droga: Part 2: TK216
Recommended dose from Part 1.
Sperimentale: Part 2 TK216 + Decitabine 20 mg/m2
Patients receive recommended dose of TK216 from Part 1 plus Decitabine.
Droga: Part 2: TK216
Recommended dose from Part 1.
Droga: Part 2: Decitabine 20 mg/m2
20 mg/m2 by vein on Days 1-10 of a 28 dayi cycle.
Altri nomi:
  • Dacogeno
Sperimentale: Expansion Phase: TK216 + Decitabine
All patients in the expansion cohort will receive the RP2D of TK216 and Decitabine.
Droga: Expansion Phase TK216
Expansion cohort will receive the RP2D of TK216
Droga: Expansion Phase Decitabine
Expansion cohort will receive the RP2D of Decitabine
Altri nomi:
  • Dacogeno

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of adverse events
Lasso di tempo: Up to 30 days
Will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.
Up to 30 days
Response rate
Lasso di tempo: Up to 30 days
Will be estimated alone with 95% confidence interval.
Up to 30 days
Overall survival
Lasso di tempo: Up to 1 year
Will be estimated using the Kaplan-Meier method.
Up to 1 year
Disease free survival
Lasso di tempo: Up to 1 year
Will be estimated using the Kaplan-Meier method.
Up to 1 year
Duration of disease control
Lasso di tempo: Up to 1 year
Will be estimated using the Kaplan-Meier method.
Up to 1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

M.D. Anderson Cancer Center

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Tapan Kadia, M.D. Anderson Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

31 marzo 2019

Completamento primario (Anticipato)

31 dicembre 2020

Completamento dello studio (Anticipato)

31 dicembre 2020

Date di iscrizione allo studio

Primo inviato

20 novembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

21 novembre 2018

Primo Inserito (Effettivo)

23 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2019

Ultimo verificato

1 maggio 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2018-0495 (Altro identificatore: M D Anderson Cancer Center)
  • P30CA016672 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2018-02667 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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