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Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05461664
Recruitment Status : Not yet recruiting
First Posted : July 18, 2022
Last Update Posted : July 18, 2022
Sponsor:
Collaborators:
Peking University Cancer Hospital & Institute
Fudan University
Peking University People's Hospital
Chinese PLA General Hospital
Xiangya Hospital of Central South University
Peking University Shenzhen Hospital
Nanfang Hospital, Southern Medical University
West China Hospital
Jiangsu Cancer Institute & Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Xijing Hospital
Shengjing Hospital
Shanghai Jiao Tong University School of Medicine
Liaoning Cancer Hospital & Institute
Sixth Affiliated Hospital, Sun Yat-sen University
Fujian Medical University Union Hospital
Cancer Hospital of Guangxi Medical University
Wuhan Union Hospital, China
First Affiliated Hospital of Chongqing Medical University
Chongqing University Cancer Hospital
Information provided by (Responsible Party):
Xinhua Zhang, MD, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
This is a prospective, multicenter, observational real-world study to explore the Avapritinib therapy in GIST patients who definited Non-exon18 Mutations of PDGFRA.

Condition or disease
Gastrointestinal Stromal Tumors Unresectable Solid Tumor Recurrent Metastatic Malignant Neoplasm

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Avapritinib in the Treatment of Unresectable or Recurrent Metastatic Gastrointestinal Stromal Tumors Non-exon18 Mutations of PDGFRA:A Real-world Study
Estimated Study Start Date : July 10, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024





Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 years ]
    To evaluate objective response rate (ORR,CR+PR) determined by radiology assessment per mRECIST(Response Evaluation Criteriain Solid Tumours), version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring < 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.

  2. Clinical Benefit Rate [ Time Frame: 2 years ]
    To evaluate clinical benefit rate(CBR,CR+PR+>16 weeks continuation SD) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring < 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.

  3. Duration Of Response [ Time Frame: 2 years ]
    To evaluate duration of response (DOR) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring < 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    To evaluate PFS determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring < 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.

  2. overall survival [ Time Frame: 2 years ]

    To evaluate OS determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.

    To evaluate OS determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring < 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.


  3. Treatment-emergent adverse events [ Time Frame: 2 years ]
    To evaluate treatment-emergent adverse events determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.

  4. adverse events of special interest [ Time Frame: 2 years ]
    To evaluate adverse events of special interest determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.

  5. serious adverse events [ Time Frame: 2 years ]
    To evaluate serious adverse events determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately 74 patients with metastatic or unresectable advanced gastrointestinal stromal tumors from tier-3 hospitals who meet the criteria will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Patients who are aged ≥ 18 years.
  • Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and/or DOG-1-positive by immunohistochemistry.
  • Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness).
  • Treatment with Avapritinib.
  • Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
  • Patient informed consent and signed written consent form.
  • The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures.

Exclusion Criteria:

  • KIT or PDGFRA wild type.
  • Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression.
  • Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the 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): NCT05461664


Contacts
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Contact: Xinhua Zhang, PhD +8620-87332200 zhangxinhua@mail.sysu.edu.cn

Sponsors and Collaborators
Xinhua Zhang, MD
Peking University Cancer Hospital & Institute
Fudan University
Peking University People's Hospital
Chinese PLA General Hospital
Xiangya Hospital of Central South University
Peking University Shenzhen Hospital
Nanfang Hospital, Southern Medical University
West China Hospital
Jiangsu Cancer Institute & Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Xijing Hospital
Shengjing Hospital
Shanghai Jiao Tong University School of Medicine
Liaoning Cancer Hospital & Institute
Sixth Affiliated Hospital, Sun Yat-sen University
Fujian Medical University Union Hospital
Cancer Hospital of Guangxi Medical University
Wuhan Union Hospital, China
First Affiliated Hospital of Chongqing Medical University
Chongqing University Cancer Hospital
Investigators
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Principal Investigator: Xinhua Zhang, PhD First affiliated hosptial,Sun Yat-sen university
Publications of Results:
中国临床肿瘤学会胃肠间质瘤专家委员会. 中国胃肠间质瘤诊断治疗共识(2017 年版). 肿瘤综合治疗电子杂志. 2018;4(1): 31-42.

Other Publications:
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Responsible Party: Xinhua Zhang, MD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT05461664    
Other Study ID Numbers: No.[2022]107
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Zhang, MD, First Affiliated Hospital, Sun Yat-Sen University:
Avapritinib
Genetic testing
Additional relevant MeSH terms:
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Neoplasms
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Recurrence
Disease Attributes
Pathologic Processes