Entacapone Combination With Imatinib for Treatment of GIST
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|ClinicalTrials.gov Identifier: NCT04006769|
Recruitment Status : Not yet recruiting
First Posted : July 5, 2019
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor, Malignant||Drug: Entacapone Drug: Imatinib Mesylate||Early Phase 1|
Most patients with Metastatic/unresectable Gastrointestinal stromal tumors will progress on the treatment of tyrosine kinase inhibitor(TKI) including Imatinib and Sunitinib.
Entacapone and imatinib can each inhibit the role of v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog(KIT) which is a kind of transmembrane receptor tyrosine kinase promoting the clonal proliferation and growth of GIST cells, but they do so by different mechanisms.
Entacapone has been approved from China Food and Drug Administration(cFDA) for controlling the symptom of Parkinson' s disease in the combination with levodopa. Recently, entacapone was identified to be an inhibitor of Fat mass and obesity-associated protein(FTO) enzyme, which was reported as the first N6-methyladenosine (m6A) demethylase of eukaryotic messenger RNA(mRNA). Entacapone can inhibit the transcriptional level of KIT mRNA leading to the decreased expression of KIT protein.
Imatinib mesylate, an oral multiple TKI targeting the KIT-oncoprotein, was the standard first-line therapy of c-KIT-mutated GISTs. Imatinib can prohibit the activation of mutated c-KIT tyrosine kinase and then impede the kinase cascade of c-KIT signal pathway.
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Entacapone & Imatinib mesylate
Entacapone 200mg tablet by mouth, three times a day and then increasing to 400mg tablet by mouth, three times a day 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
- Objective response rate(ORR) [ Time Frame: 30 days, 90days, 180days ]the total proportion of patients with reduction in tumor burden of a predefined amount. The ORR is the sum of complete response(CR)+partial responses(PR) per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Disease control rate(DCR) [ Time Frame: 30 days, 90days, 180days ]the total proportion of patients who demonstrate a response to treatment. The DCR is the sum of complete response(CR)+partial responses(PR)+ stable disease(SD) per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
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
|Contact: Zhi Li, PHDfirstname.lastname@example.org|
|Contact: Lun-Quan Sun, PHDemail@example.com|
|Bin Li, MD|
|Changsha, Hunan, China, 410008|
|Contact: Bin Li, MD +8613467713587 firstname.lastname@example.org|
|Principal Investigator:||Bin Li, MD||Xiangya Hospital, Central South University, Changsha, Hunan,China,410008|