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A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR Mutant Lung Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2014 by MedicalLogic.
Recruitment status was  Recruiting
Kosin University Gospel Hospital
Information provided by (Responsible Party):
Chang-gyu Choi, MedicalLogic Identifier:
First received: May 7, 2014
Last updated: May 20, 2014
Last verified: May 2014
  1. 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
  2. Endpoints Primary Endpoint : tumour response rate Secondary Endpoint : progression-free survival, overall survival, and safety assessment
  3. 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.

  4. Treatment method Erlotinib (Tarceva 150 mg/day) and Silybin (Siliphos 1g bid/day) q 4 weeks
  5. 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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Erlotinib
Dietary Supplement: Silybin-phytosome
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by MedicalLogic:

Primary Outcome Measures:
  • Tumour response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Efficacy assessment will be conducted through measurement of lesions by CT and RECIST criteria.

Secondary Outcome Measures:
  • Safety assessment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    For toxicity assessment, posttreatment recurrence and survival rates will be investigated based on NCI-CTCAE ver 4.0 and RTOG.

Estimated Enrollment: 42
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib and Silibin Drug: Erlotinib
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

  Show Detailed Description


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Histological or cytologic diagnosis of stage IV lung adenocarcinoma and confirmed EGFR mutation
  • 2. Patients who have not received chemotherapy before. However, patients who received postoperative adjuvant chemotherapy more than 6 months ago are eligible.
  • 3. Patients with a lesion that can be measured a response-evaluation according to the RECIST criteria (at least one evaluable lesion)
  • 4. Patients aged 20 years or older
  • 5. ECOG performance status score of 0, 1 or 2
  • 6. Expected lifetime of ≥3 months
  • 7. Adequate bone marrow and liver functions maintained

    1. Neutrophil count: > 1,500/㎕
    2. Platelet count: > 100,000/㎕
    3. Hb: > 9.0g/dL
    4. AST/ALT: < 2.0 x upper normal limit
    5. Bilirubin: < 1.25 x upper normal limit
  • 8. Patients or their legally acceptable representatives must complete a written consent before initiation of the study and patients can comply with requirements for the study

Exclusion Criteria:

  • 1. Symptomatic central nervous system (CNS) malignant tumour or metastasis. However, the patients who are treated for CNS metastasis can be enrolled if their disease is radiologically stable and asymptomatic. Asymptomatic patients without a history of CNS metastasis do not need screening.
  • 2. Evidence of severe or uncontrolled systemic diseases at the investigator's discretion (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal diseases)
  • 3. Patients who have been treated with EGFR inhibitors before
  • 4. Patients treated with other investigational products or unapproved drugs within 28 days before enrollment in this study
  • 5. Pregnant and lactating women, and patients of childbearing who do not agree to use contraception
  • 6. Patients ineligible for the study at the investigator's discretion
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02146118

Contact: JIn Hyun Park 821037451469

Korea, Republic of
Gosin University Gospel Hospital Recruiting
Busan, Korea, Republic of, 602-702
Sponsors and Collaborators
Kosin University Gospel Hospital
Study Director: Tae won Jang, Dr Kosin University Gospel Hospital
  More Information

Responsible Party: Chang-gyu Choi, Manager, MedicalLogic Identifier: NCT02146118     History of Changes
Other Study ID Numbers: SLB-001 
Study First Received: May 7, 2014
Last Updated: May 20, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by MedicalLogic:
EGFR mutant lung adenocarcinoma

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs processed this record on October 21, 2016