CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
CS-1008 +2 moredrug
Likely dose
CS-1008 10 mg/kgfrom 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/NCT00945191
NCT00945191Phase 2Completed
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Phase 2 Study of CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer

Daiichi Sankyo·interventional·Posted Jul 24, 2009·Updated Apr 8, 2021

In Brief

A Phase 2 clinical trial evaluating CS-1008, Paclitaxel, and 1 other intervention for Ovarian Cancer Stage IIIC and Ovarian Cancer Stage IV. Completed, enrolled 24 participants across 3 sites.

Detailed Summary

This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer Stage IIIC, Ovarian Cancer Stage IV
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2009
Enrollment StartOct 6, 2009
Primary CompletionAug 23, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.9 years ago

Interventions

CS-1008drug

CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6

Paclitaxeldrug

Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles

Carboplatindrug

Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles