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Trial Title:
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
NCT ID:
NCT02140606
Condition:
Leukemia, Myeloid, Acute
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
AML
phase1
MTD
Cafusertib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cafusertib Hydrochloride
Description:
Drug: Cafusertib Hydrochloride (d1 and 15) Cafusertib (d1 and 15 - one hour iv.v) Drug:
Cytarabine Cytarabine 2 x 20 mg/d s.c. d1-15.
Arm group label:
Cafusertib Hydrochloride + Cytarabine
Summary:
To investigate safety, tolerability of cafusertib combination with low dose cytarabine
(LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for
conventional or intensive treatment. The dose of cafusertib will be escalated to
determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of
cafusertib in combination with LD-Ara-C in AML patients. At the same time,
pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed
in AML patients. To determine the recommended dosage regimen for phase II.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed written informed consent consistent with Chinese Good Clinical Practice.
- Male or female patients of age >/= 18 years at the time of informed consent.
- Patients with relapsed/refractory AML ineligible for conventional or intensive
treatment.
- Eastern Cooperative Oncology Group performance status score 0 - 2 at screening.
- Life expectancy of at least 3 months.
- Adequate hepatic, renal and metabolic function parameters: Serum total bilirubin
≤1.5 x upper limit of normal, aspartate transaminase (AST) , alanine transaminase
(ALT) ≤2.5 x upper limit of normal; Creatinine clearance rate ≥60ml/min, Serum
creatinine ≤1.0 x upper limit of normal; Relatively normal ECG(electrocardiogram),
QTc<450 ms(male) ,QTc<470 ms(female); LVEF>50%.
- Patients who can comply with the trial and follow-up procedures.
Exclusion Criteria:
- Patients had received cafusertib hydrochloride or other PLK inhibitors.
- Patients with APL.
- Patients with central nervous system leukemia.
- Need to continue using cytokine therapy at screening.
- Patients participated in other clinical trials within 4 weeks prior to enrollment.
- Patient with severe infection.
- Patients with myocardial infarction had occurred within six months prior to
enrollment.
- Severe heart disease, including NYHA class II cardiac dysfunction and above.
- Patients with HIV infection or acute and chronic viral hepatitis.
- Severe gastrointestinal disorders (bleeding, infection, obstruction or greater than
grade 1 diarrhea).
- A previous history of neurological or psychiatric disorders, including epilepsy or
dementia.
- Concomitant medications with CYP3A4 inhibitors, inducers or substrates; Women
pregnant or breast feeding.
- Subject is thought unfit for this study by investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jianxiang Wang
Email:
Principal Investigator
Start date:
May 2014
Lead sponsor:
Agency:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02140606
