Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

NCT ID: NCT02140606

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

Brief 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.

Conditions

Leukemia, Myeloid, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cafusertib Hydrochloride + Cytarabine

Cafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride.

Group Type: EXPERIMENTAL

Cafusertib Hydrochloride

Intervention Type: DRUG

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.

Interventions

Cafusertib Hydrochloride

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital of Blood Diseases, Chinese Academy of Medical Sciences

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxiang Wang

Role: CONTACT

022 239099120

Other Identifiers

HS-10159-I-01

Identifier Type: -

Identifier Source: org_study_id