A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR Mutant Lung Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02146118|
Recruitment Status : Unknown
Verified May 2014 by Chang-gyu Choi, MedicalLogic.
Recruitment status was: Recruiting
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
- Title and stage of study A Phase II Study to Assess Efficacy of Combined Treatment with Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients with EGFR mutant lung adenocarcinoma
- Endpoints Primary Endpoint : tumour response rate Secondary Endpoint : progression-free survival, overall survival, and safety assessment
Study Rationale Even though it is commonly accepted that EGFR TKIs are effective to EGFR mutation positive lung cancer patients, still remains its resistance issue.
The Silybin which is extract from mugwort bean Thistle and used for hepatoprotective drug for a long time with very low adverse events in Eastern countries. Recently, there are some reports regarding its anti-cancer effects through several preclinical studies.
The safety of Siliphos which is developed agent from silybin for improving intestinal absorption was demonstrated in PhaseⅠtrial.
Recently investigators found out Silybin is effective for blocking EGFR signal in different mechanism from Erlotinib and it can be expected additional impact with combination therapy with preclinical data.
Our research team can expect to improve Lung cancer treatment if the combination therapy (Silybin_Erlotinib) improves patients' response and Overall survivor.
- Treatment method Erlotinib (Tarceva 150 mg/day) and Silybin (Siliphos 1g bid/day) q 4 weeks
- Assessment criteria For toxicity assessment, posttreatment recurrence and survival rates will be investigated based on NCI-CTCAE ver 4.0 and RTOG. Efficacy assessment will be conducted through measurement of lesions by CT and RECIST criteria. Overall survival (OS), progression-free survival (PFS), and time to tumour progression (TTP) will be estimated using a Kaplan-Meier analysis. In addition, effect of pre-treatment T790M on response and PFS will be analyzed.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Erlotinib Dietary Supplement: Silybin-phytosome||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR(Epidermal Growth Factor Receptor) Mutant Lung Adenocarcinoma|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||March 2016|
|Experimental: Erlotinib and Silibin||
Erlotinib 150 mg/day q 4 weeks
Other Name: Tarceva
Dietary Supplement: Silybin-phytosome
Silybin-phytosome 1g bid/day q 4 weeks
Other Name: Siliphos
- Tumour response rate [ Time Frame: 12 months ]Efficacy assessment will be conducted through measurement of lesions by CT and RECIST criteria.
- Safety assessment [ Time Frame: 12 months ]For toxicity assessment, posttreatment recurrence and survival rates will be investigated based on NCI-CTCAE ver 4.0 and RTOG.
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): NCT02146118
|Contact: JIn Hyun Parkfirstname.lastname@example.org|
|Korea, Republic of|
|Gosin University Gospel Hospital||Recruiting|
|Busan, Korea, Republic of, 602-702|
|Study Director:||Tae won Jang, Dr||Kosin University Gospel Hospital|