CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01199068
First received: August 30, 2010
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: CS-7017 Drug: Erlotinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy |
Resource links provided by NLM:
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Treatment Emergent Adverse Events [ Time Frame: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]Evaluate the safety and tolerability of CS-7017 in combination with erlotinib Number of subjects reporting Treatment Emergent Adverse Events (TEAEs), as a measure of safety and tolerability.
- plasma concentration of CS-7017 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]To determine the plasma concentration of CS-7017 at Days 1, 8, 15, 22, 43, and 64 after study drug administration.
- treatment-emergent Serious Adverse Events [ Time Frame: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]Evaluate the safety and tolerability of CS-7017 in combination with erlotinib Number of subjects reporting treatment-emergent Serious Adverse Events (SAEs) as a measure of safety and tolerability.
| Enrollment: | 16 |
| Study Start Date: | June 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CS-7017+Erlotinib
Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily
|
Drug: CS-7017
CS-7017 from 0.25 mg to 0.50 mg twice a daily
Other Name: CS7017
Drug: Erlotinib
Erlotinib 150 mg once daily
Other Name: Tarceva
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)
- Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
- Male or female ≥ 18 years of age
- Anticipation of more than 3 months survival
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
- Adequate organ and bone marrow function
Exclusion Criteria:
- Prior Tyrosine Kinase Inhibitor (TKI) therapy
- Anticipation of need for a major surgical procedure or radiation therapy during the study
- Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
- Treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment
- History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe Chronic-Obstructive Pulmonary Disease (COPD) or asthma)
- Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
- Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
- Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy
- Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
- Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
- Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study treatment
- History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
- Poorly-controlled blood pressure as judged by the Investigator
Contacts and Locations More Information
No publications provided
| Responsible Party: | Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT01199068 History of Changes |
| Other Study ID Numbers: | CS7017-A-A110 |
| Study First Received: | August 30, 2010 |
| Last Updated: | December 21, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Daiichi Sankyo Inc.:
|
PPAR gamma agonist Tumor Cancer Antineoplastic Agent |
Respiratory Tract Neoplasms Erlotinib Protein Kinase Inhibitors Neoplasms |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Antineoplastic Agents Erlotinib Protein Kinase Inhibitors Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013