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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cafusertib Hydrochloride + Cytarabine | Experimental | Cafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cafusertib Hydrochloride | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR)) | minimum 4 weeks, maximum n.a. | |
| Incidence and intensity of adverse events graded according to CTCAE (version 4.0) | minimum 4 weeks, maximum n.a. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxiang Wang | Contact | 022 239099120 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Blood Diseases, Chinese Academy of Medical Sciences | Recruiting | Tianjin | 300020 | China |
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| Incidence of dose limiting toxicity (DLT) | 4 weeks |
| Pharmacokinetics of cafusertib | 4 weeks |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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