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

NCT02146118 | Unknown Phase 2 DMC

• 1 other identifier: SLB-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Endpoints Primary Endpoint : tumour response rate Secondary Endpoint : progression-free survival, overall survival, and safety assessment
3. 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.
4. 4.Treatment method Erlotinib (Tarceva 150 mg/day) and Silybin (Siliphos 1g bid/day) q 4 weeks
5. 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Erlotinib; Silybin-phytosome; EGFR mutant lung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Tumour response rate

  Efficacy assessment will be conducted through measurement of lesions by CT and RECIST criteria.

  12 months

Secondary Outcomes (1)

• Safety assessment

  12 months

Study Arms (1)

Erlotinib and Silibin

EXPERIMENTAL

Drug: Erlotinib; Dietary Supplement: Silybin-phytosome

Interventions

Erlotinib DRUG

Erlotinib 150 mg/day q 4 weeks

Also known as: Tarceva

Erlotinib and Silibin

Silybin-phytosome DIETARY_SUPPLEMENT

Silybin-phytosome 1g bid/day q 4 weeks

Also known as: Siliphos

Erlotinib and Silibin

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histological or cytologic diagnosis of stage IV lung adenocarcinoma and confirmed EGFR mutation
• \. Patients who have not received chemotherapy before. However, patients who received postoperative adjuvant chemotherapy more than 6 months ago are eligible.
• \. Patients with a lesion that can be measured a response-evaluation according to the RECIST criteria (at least one evaluable lesion)
• \. Patients aged 20 years or older
• \. ECOG performance status score of 0, 1 or 2
• \. Expected lifetime of ≥3 months
• \. Adequate bone marrow and liver functions maintained
• Neutrophil count: \> 1,500/㎕
• Platelet count: \> 100,000/㎕
• Hb: \> 9.0g/dL
• AST/ALT: \< 2.0 x upper normal limit
• Bilirubin: \< 1.25 x upper normal limit
• \. 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

You may not qualify if:

• \. 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.
• \. Evidence of severe or uncontrolled systemic diseases at the investigator's discretion (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal diseases)
• \. Patients who have been treated with EGFR inhibitors before
• \. Patients treated with other investigational products or unapproved drugs within 28 days before enrollment in this study
• \. Pregnant and lactating women, and patients of childbearing who do not agree to use contraception
• \. Patients ineligible for the study at the investigator's discretion

Sponsors & Collaborators

• MedicalLogic: lead
• Kosin University Gospel Hospital: collaborator

Study Sites (1)

Gosin University Gospel Hospital

Busan, Busan, 602-702, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; silybin-phytosome

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tae won Jang, Dr

  Kosin University Gospel Hospital

  STUDY DIRECTOR

Central Study Contacts

JIn Hyun Park

CONTACT

821037451469; jhpark@medicallogic.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 23, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

KR (1)