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The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.

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ClinicalTrials.gov Identifier: NCT03384511
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
ShuanghuYuan, Shandong Cancer Hospital and Institute

Brief Summary:

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can predict the efficacy and adverse events of apatinib in patients with malignancies.

Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. The arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will monitor the antiangiogenic status.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies.


Condition or disease Intervention/treatment Phase
Malignancies Stomach Cancer Non-small Cell Lung Cancer Esophageal Cancer Breast Cancer Ovary Cancer Cervical Cancer Drug: Apatinib Phase 4

Detailed Description:

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 positron emission tomography/computed tomography (18F-RGD PET/CT) scan can predict the efficacy and adverse events of apatinib in patients with malignancies.

Angiogenesis, the formation of new blood vessels, is the process of generating neovascularization from preexisting vessels. It can promote tumor growth and metastasis by providing nutrients and oxygen. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. Since the arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity, RGD PET/CT may be helpful to evaluate the biological and metabolic activity status during angiogenesis. However, 18F-ALF-NOTA-PRGD2 PET/CT as response biomarker for antiangiogenic therapy has not been fully proved and is still without universal understanding according to current publications. Apatinib (YN968D1) is the first orally antiangiogenic drug targeting VEGFR-2 tyrosine kinase.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies. Patients confirmed malignancies histopathologically will be prospectively enrolled in the study. All patients provided written informed consent prior to enrollment. Patients will receive apatinib therapy, and undergo 18F-RGD PET/CT scans berore and after first cycle of therapy.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Apatinib at oral dose of 250 mg twice daily (500 mg/day) for a minimum of 30 days
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whether 18F-ALF-NOTA-PRGD2 PET/CT Scan Can Predict the Efficacy and Adverse Events of Apatinib in Patients With Malignancies.
Actual Study Start Date : September 30, 2016
Actual Primary Completion Date : January 28, 2018
Actual Study Completion Date : January 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib & RGD PET/CT
All of the patients will receive apatinib at oral dose of 250 mg twice daily (500 mg/day) at least 30 days.One treatment cycle is defined as 4 weeks.18F-ALF-NOTA-PRGD2 PET/CT scan will be performed berore and after one cycle of therapy. Treatment interruptions or dose reductions to 250 mg/day will be allowed for the management of adverse events. The maximum allowable period of treatment interruption is 1 week during each treatment cycle, and the dose should be re-escalated to 500 mg/day after adverse events mitigation. Treatment will not stop until disease progression, intolerable toxicity, or patients' request for withdrawal from the study.
Drug: Apatinib
Patients will accept apatinib therapy and undergo baseline 18F-ALF-NOTA-PRGD2 PET/CT scans of the whole body after having met all eligibility criterias.
Other Name: YN968D1




Primary Outcome Measures :
  1. Tumor response defined by RECIST criteria [ Time Frame: At 1 month of the study ]
    Tumor response will be evaluated as complete response or partial response or stable disease or PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.


Secondary Outcome Measures :
  1. Days from the start of therapy to disease progression or death due to any cause [ Time Frame: At 6 months of the study ]
    Progression free survival (evaluated by RECIST criteria), defined as the interval from start of therapy to investigator-assessed progression or death due to any cause, whichever occurs first or lost of follow-up.

  2. Days from the start of therapy to death due to any cause [ Time Frame: Up to 12 months ]
    Overall survival is the time interval from the start of therapy to death due to any reason or lost of follow-up.

  3. Treatment-Related Adverse Events as Assessed by CTCAE [ Time Frame: Through study completion, an average of 6 months ]
    Common Terminology Criteria for Adverse Events (CTCAE)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of malignancies
  • Scheduled for second- or third-line apatinib therapy
  • Karnofsky performance status (KPS) ≥70
  • Measurable primary tumors according to Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

  • Active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy
  • The claustrophobic patients and patients with implanted metal objects
  • The pregnancy
  • Inability to complete the required examinations

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): NCT03384511


Locations
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China, Shandong
Jinan, Shandong, China, 250117
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Principal Investigator: Shuanghu Yuan, MD;PhD Shandong Cancer Hospital and Institute

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Responsible Party: ShuanghuYuan, M.D., Ph.D., Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03384511     History of Changes
Other Study ID Numbers: CRTOG1701
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by ShuanghuYuan, Shandong Cancer Hospital and Institute:
RGD PET-CT
Apatinib

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Ovarian Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases