CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Linsitinib +3 moredrug
Likely dose
Linsitinib 150 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/NCT01533181
NCT01533181Phase 2Completed

Randomized Phase II Study of Single Agent OSI-906, an Oral, Small Molecule, Tyrosine Kinase Inhibitor (TKI) of the Insulin Growth Factor-1 Receptor (IGF-1R) Versus Topotecan for the Treatment of Patients With Relapsed Small Cell Lung Cancer (SCLC)

National Cancer Institute (NCI)·interventional·Posted Feb 15, 2012·Updated Jan 14, 2016

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Linsitinib, and 2 other interventions for Recurrent Small Cell Lung Carcinoma. Completed, enrolled 44 participants across 11 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate how OSI-906 compares to Topotecan in trying to slow down the growth and/or progression of the tumors of participants with relapsed or recurrent Small Cell Lung Cancer. This study also plans to find out what effects, good or bad (side effects), OSI-906 has on participants and or Small Cell Lung Cancer. The study will also investigate if some proteins measured in the blood or tumor and some imaging features obtained from computed tomography (CT) scans can help predict whether OSI-906 or topotecan will be effective against Small Cell Lung Cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSingapore, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2012
Enrollment StartFeb 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.4 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Linsitinibdrug

150 mg given orally (PO) twice a day (BID)

Pharmacological Studyother

Correlative studies

Topotecan Hydrochloridedrug

1.5 mg/m\^2 intravenously (IV) or 2.3 mg/m\^2 orally (PO)