At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 17 enrolled
Drug / intervention
Erlotinib plus Romidepsin (8 mg/m^2) +3 morecombination
Likely dose
Erlotinib plus Romidepsin (8 mg/m^2)from 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.
A Phase I/II Study of Erlotinib and Romidepsin in Advanced Non-Small Cell Lung Cancer
University of Texas Southwestern Medical Center·interventional·Posted Feb 24, 2011·Updated Jan 20, 2021
In Brief
A Phase 1 clinical trial evaluating Erlotinib plus Romidepsin (8 mg/m^2), Erlotinib plus Romidepsin (10 mg/m^2), and 2 other interventions for Lung Cancer and Metastatic Cancer. Completed, enrolled 17 participants across 1 site.
Detailed Summary
RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when given together with erlotinib hydrochloride and to see how well they work in treating patients with stage III or stage IV non-small cell lung cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Metastatic Cancer
CountriesUnited States
CollaboratorsCelgene, Genentech, Inc.
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedFeb 2011
Primary CompletionDec 2014
TodayJul 2026
First PostedFeb 24, 2011
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.4 years ago
Interventions
Erlotinib plus Romidepsin (8 mg/m^2)combination
Erlotinib plus Romidepsin (10 mg/m^2)combination
Erlotinib plus Romidepsin (10 mg/m^2) + Antiemetic prophylaxiscombination
(Erlotinib plus Romidepsin (8mg/m^2)) + Antiemetic prophylaxiscombination