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|
|Primary Completion Date :||December 2011|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|