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ZD4054 10 mg given orally, once daily in tablet form to all patients in two years or until investigator consider the drug for useless.

ZD4054

Michael Borre, MD Phd DMSc

This is a prospective, open, one-arm, two-centre, Phase II clinical safety pilot-study. The trial is designed to gain initial safety and efficacy-related data on once-daily orally administered ZD4054 10 mg in prior chemotherapy treated patients with metastatic hormone-resistant prostate cancer.

Study centres and number of patients planned This pilot study will be conducted in approximately 24 patients recruited from two hospital-based Danish centres: department of Urology K, Aarhus University Hospital, Skejby and department of Urologic Surgery D, Rigshospitalet. The recruitment of patients will be competitive among centres. 1-2 months before expected LSI it should be discussed if the target accrual should be expanded.

Study period Phase of development Estimated date of first patient enrolled August 1th 2009 II Estimated date of last patient completed July 31th 2012 Total study duration is approximately 36 months, which includes 12 months' recruitment, 36-month follow-up for safety and final survival analysis.

Objectives

The primary objective of this study is:

To assess the safety and tolerability profile of ZD4054 after treatment with chemotherapy

* Adverse events
* Vital signs
* Laboratory data
* ECGs
* Physical Exam
* Death from any cause

The secondary objectives of the study are:

1. To investigate the effect of ZD4054 on rate of rise of PSA
2. To investigate the effect of ZD4054 on prostate cancer related pain
3. To investigate the effect of ZD4054 on the plasma concentration of circulating tumour cells (CTC).

In addition, Time to Progression and Overall Survival (time to death) will be compared with historical data in a post chemotherapy population.

Study design This is a prospective, Open, One-arm, Phase II clinical safety pilot-study. The trial is designed to gain initial safety and efficacy-related data on once-daily orally administered ZD4054 10 mg in prior chemotherapy treated patients with metastatic hormone-resistant prostate cancer.

Patients could receive other therapies including prednisolone, estramustine, ketoconazole and second-line or third-line antiandrogens at investigator's discretion without being considered treatment failures or having to stop study therapy; however every attempt will be made to avoid changes in medication for at least 12 weeks to minimise potential for confounding on study endpoints over this time period. Chemotherapy and radiation therapy may also be administered in addition to study therapy at investigator's discretion after objective progression if the patient is considered likely to derive benefit. Patients will be followed to death.

Target patient population A total number of 24 male patients aged 18 years or older with metastatic hormone-resistant prostate cancer who have progressive disease (defined by rising serum prostate-specific antigen levels despite medical or surgical castration) and previously received cytotoxic chemotherapy (docetaxel) for the treatment of HRPC.

Investigational product, dosage and mode of administration

Patients will not be randomised and all patients will receive:

• ZD4054 10 mg given orally, once daily in tablet form. Duration of treatment Patients will receive daily ZD4054 as long as they meet no withdrawal criteria. Following completion of 24 months of ZD4054, patients, who in the investigator's opinion are experiencing benefit from study treatment, may continue on ZD4054, for as long as they meet no withdrawal criteria.

Statistical methods The study is a pilot study designed to collect safety/tolerability data and assess markers of efficacy. A total of 24 patients will be recruited into this pilot study and this is based primarily on the number of patients that can be recruited in a reasonable time period at the centres and should be sufficient to make an initial assessment of safety/tolerability and the efficacy markers.

For the assessment of tolerability and safety, incidence and severity of adverse events (AEs) (based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (NCI CTCAE) grading), laboratory values, vital signs, ECGs and physical exam will be summarised.

Secondary endpoints will be presented and analysed to investigate trends in the data. The interpretation of the analyses will consider the number of assessments being undertaken.

Pain will be assessed using the Brief Pain Inventory Demography and baseline data will be summarised. Any analyses will be performed using SPSS and other validated software as appropriate.

A Safety Study of ZD4054 in Prior Chemotherapy Treated Patients With Metastatic Hormone-resistant Prostate Cancer

An Open Phase II, Two-centre, 1-Arm Safety Study of Once-daily Orally Administered 10 mg ZD4054 in Prior Chemotherapy Treated Patients With Metastatic Hormone-resistant Prostate Cancer

Rigshospitalet, Denmark

Aarhus University Hospital

Professor, DMSci, PhD

Blood and Lymph Conditions

Immune System Diseases

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Lymphosarcoma

Acute Graft Versus Host Disease

The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.

CD19-CAR-T2 Cells

Xin Du, Dr.

Peng Li, Dr.

Jianyu Weng, Dr.

Peilong Lai, Dr.

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.

Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia

CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial

Adverse events and laboratory abnormalities (type, frequency and severity)

Overall Response Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

Chinese Academy of Sciences

Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Guangdong Provincial People's Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Safety Study of ZD4054 in Prior Chemotherapy Treated Patients With Metastatic Hormone-resistant Prostate Cancer	NCT01000948	Prostate Cancer Metastasis	ZD4054	18 Years - 90 Years	Aarhus University Hospital
Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia	NCT02822326	Acute Leukemia	CD19-CAR-T2 Cel...	14 Years - 65 Years	Guangdong Provincial People's Hospital

Spots Global Cancer Trial Database for chemotherapy resistant