Clinical trial NCT01101334: Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
Official title: Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline to disease progression or death, up to approximately 2.5 years
Secondary outcomes:
measure: 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
timeFrame: Baseline to death, up to approximately 2.5 years
measure: Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
timeFrame: Baseline to disease progression or death, up to approximately 2.5 years
measure: 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
timeFrame: Baseline to 30 days after last dose, up to approximately 2.5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: DHHA
state: Colorado
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Gauting
country: Germany
facility: Zentrum fur Pneumologie und Thoraxchirurgie
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Vedanta Institute of Medical Sciences
state: Gujarat
city: Aurangabad
country: India
facility: Kodlikeri Memorial Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Pune
country: India
facility: Noble Hospital
state: Maharastra
city: Chennai
country: India
facility: Apollo Speciality Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Meenakshi Mission Hospital
state: Tamil Nadu
city: Kolkata
country: India
facility: Orchid Nursing Home
state: West Bengal
city: Gyeonggi-Do
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Jeonnam
country: Korea, Republic of
facility: Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: