CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
CS-7017 +2 moredrug
Likely dose
CS-7017 0.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01199055
NCT01199055Phase 1Completed
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Phase 1b Study of CS-7017 in Combination With Carboplatin/Paclitaxel in Chemotherapy-naïve Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Daiichi Sankyo Co., Ltd.·interventional·Posted Sep 10, 2010·Updated Jul 7, 2020

In Brief

A Phase 1 clinical trial evaluating CS-7017, Carboplatin, and 1 other intervention for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of CS-7017 in combination with carboplatin and paclitaxel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesSouth Korea
CollaboratorsICON Clinical Research

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartMar 1, 2010
Primary CompletionApr 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.8 years ago

Interventions

CS-7017drug

Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4\~6 cycles (1 cycle: 3 weeks)

Carboplatindrug

Drug: Carboplatin IV, AUC of 6 mg/mL\*min, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)

Paclitaxeldrug

Drug: Paclitaxel IV, 200mg/m\^2, once every three weeks for up to 4\~6 cycles (1 cycle: 3 weeks)