Trials / Withdrawn
WithdrawnNCT03752138
TK216 and Decitabine in Treating Patients With Relapsed and Refractory Acute Myeloid Leukemia
Phase I Study of TK216 in Patients With Relapsed and Refractory Leukemias
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Group 1: TK216 | Starting Dose: 288 mg/m2 given by vein on Days 1-7 of a 21 day cycle. |
| DRUG | Group 2: TK216 | Starting Dose: 144 mg/m2 given by vein on Days 1-7 and 15-21 of a 23 day cycle. |
| DRUG | Part 2: Decitabine 10mg/m2 | 10mg/m2 by vein on Days 1-10 of a 28 day cycle. |
| DRUG | Part 2: Decitabine 20 mg/m2 | 20 mg/m2 by vein on Days 1-10 of a 28 dayi cycle. |
| DRUG | Expansion Phase TK216 | Expansion cohort will receive the RP2D of TK216 |
| DRUG | Expansion Phase Decitabine | Expansion cohort will receive the RP2D of Decitabine |
| DRUG | Part 2: TK216 | Recommended dose from Part 1. |
Timeline
- Start date
- 2019-03-31
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2018-11-23
- Last updated
- 2019-05-06
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03752138. Inclusion in this directory is not an endorsement.