Entacapone Combination With Imatinib for Treatment of GIST
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|ClinicalTrials.gov Identifier: NCT04006769|
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : October 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor, Malignant||Drug: Entacapone Drug: Imatinib Mesylate||Early Phase 1|
The eligibility criteria are patients whose histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor (GIST) of c-KIT E11 mutation genotype. He received imatinib as the first-line treatment and no progression within the first 6 months (no primary resistance to imatinib), with disease progression following treatment with at least imatinib and sunitinib, and at least 1 measurable lesion (the longest diameter≥ 10mm). Age should be more or equal 18 years with adequate hematologic and end-organ function and good performance ((ECOG PS) ≤ 2, or 3 (the symptoms were definitely caused by GIST itself).
This study is single group assignment and open label. The intervention/treatment is Entacapone combined with Imatinib. Entacapone began with 200mg tablet (Orion pharma, Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Periodically routine blood test including liver and kidney function, troponin and electrocardiogram were conducted throughout the entire clinical course.
Clinic visits are performed at 16 points: visit 1, baseline, and then follow up after first dose as planned: 1st month, and every 2 months in the first year, followed by every 3 months until 3 years or 31 days after withdraw. The study design is visualized in Figure 1 below.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib|
|Actual Study Start Date :||October 30, 2020|
|Actual Primary Completion Date :||August 31, 2022|
|Actual Study Completion Date :||August 31, 2022|
Experimental: Entacapone & Imatinib mesylate
Entacapone 200mg tablet (Orion pharma,Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first.
And Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first.
Drug: Imatinib Mesylate
Imatinib Mesylate tablet
Other Name: Gleevec
- Adverse Events (AE) And Serious Adverse Events(SAE) [ Time Frame: 36 months or 31 days after last dose, which come first. ]According to Criteria CTCAE5.0, the ratio of AE and SAE which were defined by the Common Terminology Criteria for Adverse Events, CTCAE.
- Objective Response Rate(ORR) [ Time Frame: 36 Months ]The ORR is the proportion of the patients who achieved complete response (CR) or partial responses(PR) according to CHOI criteria.
- Quality of Life(QOL) [ Time Frame: Difference between baseline and the timepoint of the best efficacy within 181 days. ]The data was collected using EORTC QLQ-C30 V3.0 questionnaire
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): NCT04006769
|Bin Li, MD|
|Changsha, Hunan, China, 410008|
|Principal Investigator:||Bin Li, MD||Xiangya Hospital, Central South University, Changsha, Hunan,China,410008|