CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

Sponsor
Daiichi Sankyo Co., Ltd.
Study ID
NCT01199068
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CS-7017 — DRUG
    CS-7017 from 0.25 mg to 0.50 mg twice daily
  • Erlotinib — DRUG
    Erlotinib 150 mg once daily

Study Details

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.

Key Dates

First listed
Sep 10, 2010
Start date
Jun 30, 2010
Status verified
Apr 2021
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CS-7017+Erlotinib
    Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily

Primary Outcome Measure

CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy [ Time Frame: From post first dose to 30 days after last dose, up to approximately 1.5 years ]

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