- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774200
A One-arm Exploratory Clinical Research Program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma Patients.
May 12, 2016 updated by: Tianjin Medical University Cancer Institute and Hospital
A One-arm Exploratory Clinical Research Program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma Patients
A one-arm exploratory clinical research program Study of Apatinib in Advanced Metastatic Renal Cell Carcinoma (mRCC) Patients.It's arm to evaluate the treatment of advanced metastatic renal cell carcinoma in patients with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), quality of life score (QoL) and safety.
Study Overview
Detailed Description
Objective response rate (ORR), disease control rate (DCR) (according to RECIST 1.1 Standard Edition),progression-free survival (PFS), overall survival (OS), quality of life (QoL).Evaluation once every 8 weeks, If the efficacy results of the evaluation are complete response (CR) or partial response (PR), confirmed imaging efficacy at 4 weeks after the initial assessment , efficacy evaluation time window of ± 7 days.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
- Age 18 years to 75 years
- Histologically or cytologically confirmation with a renal clear cell histologic component and metastases
- Presence of a single diameter measurable lesions (eg, ≥1 malignant tumors with at least one single diameter can be accurately measured, conventional computer tomography scan [CT] or magnetic resonance [MRI] requires at least one path ≥20mm, if the interphase reconstruction of spiral computed tomography scan ≤5mm [CT], at least one path ≥10mm). Bone lesions, ascites, peritoneal metastasis or miliary lesions, pleural or pericardial effusion, skin or lung lymphangitis, cystic lesion or lesions after radiotherapy is not measurable lesion
- Life expectancy more than 3 months
- The progress of the disease must be according to RECIST criteria (version 1.0) after a previous systemic treatment of first-line metastatic renal cell carcinoma. Previous treatment program includes one or more of the following drugs: Sunitinib, Sorafenib, Bevacizumab + Interferon-α (IFN-α), Temsirolimus or Cytokine;
- Adequate organ function, defined as follows: the absolute number of Neutrophil (ANC) same or more than 1500 cells / mm3; Platelet same or more than 75,000 cells / mm3; Hemoglobin same or more than 9.0 g / dL; Aspartate aminotransferase(AST)and alanine aminotransferase (ALT) same or less than equal 2.5 x upper limit normal (xULN), if liver metastases, Aspartate aminotransferase (AST) and ALT same or less than 5.0 times ULN;Total bilirubin same or less than 1.5 times ULN,Serum Creatinine same or less than 1.5 times ULN, Creatinine clearance same or more than 60 mL/min, Urinary dipstick proteinuria <2+. If the urine protein same or more than 2+, the need for 24-hour urinary protein excretion, and 24-hour urine protein <2 g
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- The prior systemic therapy, radiation therapy, surgery at least two weeks apart (bevacizumab + IFN-α therapy for at least 4 weeks apart), all treatment-related toxicity recovered to ≤1 grade defined according to 3.0 versions of NCI CTCAE defined, or recovered to baseline levels, except for alopecia, or hypothyroidism
- The measured value of twice baseline blood pressure (interval of at least 1 hour) show inexistent Hypertension that cannot be controlled by medication. Baseline systolic blood pressure should be same or less than 140 mm Hg, baseline diastolic blood pressure should be same or less than 90 mm Hg. Patients with antihypertensive drugs can be controlled by the group
- For the fertility of women ,the serum or urine pregnancy test must be negative within pre-treatment three days
- Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Patient consent and well compliance, scheduled to accept the visits, treatment, laboratory tests and other study procedures
Exclusion Criteria:
- Patients who received more than one first-line for the Metastatic Renal Cell Carcinoma (mRCC) systemic treatment
- Patients who received any neoadjuvant or adjuvant systemic treatment
- Begin to study 4 weeks later than major surgery treatment time, or 2 weeks later than radiotherapy. Allow received palliative radiotherapy for metastatic lesion, but at least one measurable lesions did not receive radiation therapy
The gastrointestinal tract anomalies
- unable to take oral medication
- require intravenous nutrition
- previous surgical treatment influence drug absorption include total gastrectomy
- In the past six months have been treated for active ulcer disease
- In the past three months with cancer unrelated activities gastrointestinal bleeding, including vomiting blood, blood in the stool or black stools, endoscopy or colonoscopy colon without evidence of remission
- malabsorption syndrome.
- Currently accepted or may need to accept treatment with potent CYP3A4 inhibitors (eg, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, blessing Secretary amprenavir and delavirdine)
- Currently accepted or may need to accept CYP3A4 or CYP1A2 inducer treatment (eg, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine , primidone, rifabutin, rifampicin, Hypericum perforatum)
- Need to accept the oral vitamin K antagonists of anticoagulant therapy. Allows the use of low dose of anticoagulant drugs to remain central venous channel unobstructed and prevention of deep vein thrombosis. Allow treatment dose low molecular heparin
- Active epilepsy or brain metastases, spinal cord compression or meningitis carcinomatosa
- Patients who have unable to control the disease or active infection
- Situation appeared within 12 months before with the study drug: myocardial infarction, uncontrolled angina, coronary artery/peripheral artery bypass grafting, with symptoms of congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or pulmonary embolism within 6 months
- Known history of Human Immunodeficiency Virus(HIV) positive or Immune Deficiency Syndrome(AIDS) related diseases
- Medical History:Have other malignant tumors (except renal cell carcinoma), not including treatable form of skin cancer (non malignant melanoma), breast carcinoma in situ or cervical carcinoma in situ, or any other tumors has been cured, and no evidence of disease recurrence within 2 years
- Patients who are dementia or obvious mental retardation
- Women with pregnancy or lactation, or fertility but during treatment and 6 months after treatment of termination unwilling or unable to use effective contraception to avoid pregnancy patients with male or female
- With other serious acute and chronic physical or mental illness or abnormal laboratory tests, according to the judgment may increase the risk of to participate in research or related to drug treatment, or may affect the interpretation of the results, or other situations that the researchers considered unsuitable for this study
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: test group
Apatinib 500 mg, po, qd, continuous medication for a period of eight weeks.
|
Apatinib 500 mg, po, qd, continuous medication for a period of eight weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response rate (ORR)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival (PFS)
Time Frame: 8 weeks
|
8 weeks
|
overall survival (OS)
Time Frame: 8 weeks
|
8 weeks
|
quality of life score (QoL)
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peng Chen, M.D., Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
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, 2016
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 12, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Estimate)
May 17, 2016
Last Update Submitted That Met QC Criteria
May 12, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- AHEAD-HBR001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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