Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA
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ClinicalTrials.gov Identifier: NCT05461664 |
Recruitment Status :
Not yet recruiting
First Posted : July 18, 2022
Last Update Posted : July 18, 2022
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Condition or disease |
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Gastrointestinal Stromal Tumors Unresectable Solid Tumor Recurrent Metastatic Malignant Neoplasm |
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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- Treatment-emergent adverse events [ Time Frame: 2 years ]To evaluate treatment-emergent adverse events determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.
- 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.
- serious adverse events [ Time Frame: 2 years ]To evaluate serious adverse events determined in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.
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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 |
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.
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
Contact: Xinhua Zhang, PhD | +8620-87332200 | zhangxinhua@mail.sysu.edu.cn |
Principal Investigator: | Xinhua Zhang, PhD | First affiliated hosptial,Sun Yat-sen university |
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Avapritinib Genetic testing |
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 |