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

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ClinicalTrials.gov Identifier: NCT02314884
Recruitment Status : Unknown
Verified November 2014 by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Cafusertib Hydrochloride Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Cafusertib Hydrochloride
Cafusertib Hydrochloride d1q3w
Drug: Cafusertib Hydrochloride



Primary Outcome Measures :
  1. MTD of cafusertib based on the incidence of dose limiting toxicities [ Time Frame: 4 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314884


Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Lin Shen, MD    010-88196561    linshenpku@163.com   
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.

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Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02314884     History of Changes
Other Study ID Numbers: HS-10159-I-02
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: November 2014