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

December 10, 2014 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

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
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients age 18 years to 75 years at the time of informed consent
  • Eastern Cooperative Oncology Group performance status score of 0-2 at screening
  • Life expectancy of at least 12 weeks
  • At least one target tumor lesion has not been irradiated and can accurately be measure.

Patients with histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed conventional treatment, or for whom no therapy of efficacy existed.

Signed informed consent consistent with Chinese Good Clinical Practice.

Male or female patients of child-producing potential must agree to use appropriate contraceptive measures (hormones or barrier or abstinence) during the study and for 90 days after the last day of treatment, serum pregnancy test must be negative within 7 days prior to initiation of study treatment, infertile women is defined as hysterectomy, ovariotomy or menopause for at least 12 months.

Adequate bone marrow, renal and hepatic function parameters: ANC more than 2000/mm3, platelet count more than 100 000/mm3, hemoglobin more than 90 g/L; Total bilirubin less than 1.5 x upper limit of normal，ALT and AST less than 2.5 x upper limit of normal，less than 5.0 x upper limit of normal in case of liver metastases; serum creatinine less than 1.5 x upper limit of normal, creatinine clearance rate more than 50 ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate); Relatively normal ECG (electrocardiogram), QT intervals below 450 ms (male) ,QT intervals below 470 ms (female); LVEF more than 50%.

Exclusion Criteria:

Uncontrolled accumulation of coelomic fluid.

Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 4 weeks prior to initiation of study treatment, or received nitrourea or mitomycin chemotherapy within 6 weeks prior to initiation of study treatment.

  • Side effects/toxicities of such surgery that have not recovered to CTCAE grade 1
  • Patients who can't be interrupted use drugs, which may cause QT prolongation (see annex 2)
  • Patients with meningioma or current symptomatic brain metastases
  • Co-existing malignancy or malignancies diagnosed within the last 5 years with the exception of completely removed skin basal cell carcinoma or cervical cancer in situ
  • Concurrent anti-tumor therapy
  • Involved in other clinical trials less than 4 weeks prior to Day 1
  • Known hypersensitivity to more than two substances or the trial drugs and their excipients
  • Patients with serious infections
  • Patients with history of immune deficiency, including positivity to HIV antibody, or other acquired, congenital immunodeficiency disease, or history of organ transplantation
  • Known positivity to hepatitis B antigen or hepatitis C antibody
  • Patient with other serious diseases, in the investigator's opinion, can bring patients great risk. Including but not limited to the following: unstable cardiac diseases (history of myocardial infarction within 6 months prior to Day 1, New York Heart Association Class III or greater, with poorly controlled atrial fibrillation or hypertension), need long-term steroids or immunosuppressive therapy of diseases, such as rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus
  • Pregnant(positive pregnancy test) or lactating women
  • Active alcohol abuse or heavy smoker
  • A previous history of neurological or psychiatric disorders, including epilepsy or dementia
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cafusertib Hydrochloride
Cafusertib Hydrochloride d1q3w
Drug: Cafusertib Hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Time Frame: 6 weeks
6 weeks
Incidence and intensity of Adverse Events according to Common Toxicity Criteria for AEs (CTCAE version 4.0)
Time Frame: 6 weeks
6 weeks
Occurrence of dose limiting toxicities (DLT)
Time Frame: 4 weeks
4 weeks
Max concentration (Cmax) of cafusertib
Time Frame: 3 weeks
3 weeks
AUC of cafusertib
Time Frame: 3 weeks
3 weeks
Elimination half-life(T1/2) of cafusertib
Time Frame: 3 weeks
3 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

November 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 12, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • HS-10159-I-02

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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