Advanced Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
| NCT number | NCT01101334 |
| Other study ID # | CS7017-A-U204 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | March 2010 |
| Est. completion date | April 2013 |
| Verified date | June 2020 |
| Source | Daiichi Sankyo, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a Phase 2 and open-label (subject will know the treatment he or she is receiving)
study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.
The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of
survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed stage IIIB or IV NSCLC. - Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy. - Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria. - = 18 years of age. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Adequate organ and bone marrow function. - Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade = 1. - Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment. Exclusion Criteria: - Treatment with anticancer therapy within 3 weeks before study treatment. - Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases). - Administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment. - Current need for concomitant use of other TZDs during the study. - Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening. - History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction. - Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor. - Pregnant or breast feeding. - Prior treatment with epidermal growth factor receptor (EGFR) inhibitors. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Zentrum fur Pneumologie und Thoraxchirurgie | Gauting | |
| India | Vedanta Institute of Medical Sciences | Ahmedabad | Gujarat |
| India | Kodlikeri Memorial Hospital | Aurangabad | Maharashtra |
| India | Apollo Speciality Hospital | Chennai | Tamil Nadu |
| India | Orchid Nursing Home | Kolkata | West Bengal |
| India | Meenakshi Mission Hospital | Madurai | Tamil Nadu |
| India | Tata Memorial Hospital | Mumbai | Maharashtra |
| India | Noble Hospital | Pune | Maharastra |
| India | King George Hospital | Visakhapatnam | Andhra Pradesh |
| Korea, Republic of | St. Vincent's Hospital | Gyeonggi-Do | |
| Korea, Republic of | Hwasun Hospital | Jeonnam | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Severance Hospital | Seoul | |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | DHHA | Denver | Colorado |
| United States | Providence Regional Medical Center Everett | Everett | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Daiichi Sankyo, Inc. |
United States, Germany, India, Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy | Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. | Baseline to disease progression or death, up to approximately 2.5 years | |
| Secondary | Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy | Overall survival (OS) was defined as the time from randomization until death from any cause. | Baseline to death, up to approximately 2.5 years | |
| Secondary | Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy | The overall response rate (ORR) was defined as the proportion of participants who achieved best overall response of complete response (CR) or partial response (PR); ORR = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. | Baseline to disease progression or death, up to approximately 2.5 years | |
| Secondary | Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in =10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy | A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state. | Baseline to 30 days after last dose, up to approximately 2.5 years |