CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT01199068|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : December 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: CS-7017 Drug: Erlotinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily
CS-7017 from 0.25 mg to 0.50 mg twice a daily
Other Name: CS7017Drug: Erlotinib
Erlotinib 150 mg once daily
Other Name: Tarceva
- Treatment Emergent Adverse Events [ Time Frame: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ]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 ]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 ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199068
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Songpa-Gu, Korea, Republic of, 138-736|