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

May 13, 2014 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China, 300020
        • Recruiting
        • Hospital of Blood Diseases, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Jianxiang Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR))
Time Frame: minimum 4 weeks, maximum n.a.
minimum 4 weeks, maximum n.a.
Incidence and intensity of adverse events graded according to CTCAE (version 4.0)
Time Frame: minimum 4 weeks, maximum n.a.
minimum 4 weeks, maximum n.a.
Incidence of dose limiting toxicity (DLT)
Time Frame: 4 weeks
4 weeks
Pharmacokinetics of cafusertib
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-10159-I-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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