Evaluation of ETC-1907206 With Dasatinib in Advanced Haematologic Malignancies (NCT03414450) | Clinical Trial Compass
WithdrawnPhase 1
Evaluation of ETC-1907206 With Dasatinib in Advanced Haematologic Malignancies
Stopped: Withdrawal requested by D3
United States0Started 2018-04-25
Plain-language summary
This study evaluates the use of ETC-1907206 in combination with dasatinib in certain types of blood cancers. The first phase of the study (1A) is designed to find the highest tolerated dose of ETC-1907206, while the second phase (1B) will assess the safety and tolerability of the recommended dose of ETC-1907206. ETC-1907206 has been designed to block the activity of an enzyme of the body known as Mnk kinase, which is thought to be involved in the development of a variety of cancers.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
✓. Age 18 years or older (US sites) or 21 years or older (Singapore site) at Baseline.
✓. Bone marrow (BM) cytogenetic analysis with at least 20 metaphase cells, confirmed advanced haematologic malignancies in any of the 4 following disease populations at Screening:
✓. Meets definition for one of the following study subgroups:
✓. ECOG performance status of 0 to 2 at Baseline.
✓. Life expectancy of at least 3 months at Baseline.
✓. Adequate organ function at Baseline, including the following (noting that repeated tests at Baseline should not be performed unless there are sufficient reasons to assume the patient would meet the inclusion criteria with re testing):
✓. Total bilirubin ≤ 1.5 x upper limit of normal (ULN), unless resulting from haemolysis or documented Gilbert syndrome.
Exclusion criteria
What they're measuring
1
Maximum Tolerated Dose (MTD) (Phase 1A)
Timeframe: the initial 28 days of treatment
2
Phase 1B Safety: Incidence of Adverse Events (AEs) during Phase 1B
Timeframe: up to 44 months
3
Phase 1B PK: Area under the drug concentration-time curve (AUC) from time zero to infinite time (AUC0-inf)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
4
Phase 1B PK: AUC from time zero to the last measureable concentration (AUC0-t)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
5
Phase 1B PK: First-order rate constant for elimination of drug (kel)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
6
Phase 1B PK: Time to reach maximum plasma concentration (Tmax)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
7
Phase 1B PK: Time between drug administration and first observed concentration above lower limit if quantitation in plasma (Tlag)
Trial details
NCT IDNCT03414450
SponsorEDDC (Experimental Drug Development Centre), A*STAR Research Entities
✕. Is a male patient with sexual partner(s) of childbearing potential who is unwilling to use a highly effective method of contraception, one of which includes a condom. Sexually active male patients must use a condom during intercourse throughout the study and for 12 weeks after the end of treatment and should not father a child in this period. A condom is required to be used also by vasectomised males in order to prevent potential delivery of the study drug via seminal fluid. Female partners of male patients must be advised to also use one of the following contraception methods:
✕. Is a female patient of childbearing potential, defined as a female physiologically capable of becoming pregnant (including a female whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, and females whose partners have been sterilised by vasectomy or other means), unless they are using a highly effective method for birth control throughout the study and for 12 weeks after the end of treatment. Highly effective methods for birth control include the following:
✕. Is a pregnant or nursing (lactating) female, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
✕. Has dasatinib intolerance (haematologic and non-haematologic). Defined as: CTCAE Grade \>2
✕. Has received anti-cancer therapy within 2 weeks or 5 half-lives, whichever is shorter (except for hydroxyurea, steroids, allopurinol, febuxostat, rasburicase, and intravenous hydration), prior to starting study drug or the side effects of such therapy have not resolved to Grade ≤1 within 2 weeks prior to starting study drug.
✕. Is receiving concomitant anti-cancer therapy (except for hydroxyurea, steroids, anagrelide, allopurinol, febuxostat, rasburicase, and intravenous hydration during the first week of the study drug\[s\] administration, or corticosteroids when appropriate).
✕. Has used other investigational drugs within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug.
✕. Has undergone autologous or allogenic stem cell transplantation \< 60 days prior to the first dose of study drug;
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
8
Phase 1B PK: Total clearance (CL)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
9
Phase 1B PK: Volume of distribution (Vd)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing
10
Phase 1B PK: Half-life (T1/2)
Timeframe: pre-dose, at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours (± 6 minutes), and at 24, 30, and 48 hours (± 2 hours) after dosing