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Cytarabine

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

Cafusertib Hydrochloride

Jianxiang Wang

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.

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

An Open Phase I Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous Cafusertib Hydrochloride in Combination With Subcutaneous Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lin Shen, MD

A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients With Advanced Solid Tumors

To investigate safety, tolerability of cafusertib in Chinese patients with Advanced Solid Tumors 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 advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.

Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid Tumours

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)	NCT02140606	Leukemia, Myelo...	Cafusertib Hydr...	18 Years -	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)	NCT02140606	Leukemia, Myelo...	Cafusertib Hydr...	18 Years -	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid Tumours	NCT02314884	Neoplasms	Cafusertib Hydr...	18 Years - 75 Years	Jiangsu Hansoh Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for cafusertib hydrochloride