CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
cyclodextrin-based polymer-camptothecin CRLX101 +2 moredrug
Likely dose
Not stated in 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/NCT01612546
NCT01612546Phase 2Completed
CompareCT.gov

Pilot Trial of CRLX101 in the Treatment of Patients With Advanced Gastric, Gastroesophageal, or Esophageal Squamous or Adenocarcinoma

City of Hope Medical Center·interventional·Posted Jun 6, 2012·Updated Feb 1, 2018

In Brief

A Phase 2 clinical trial evaluating cyclodextrin-based polymer-camptothecin CRLX101, Laboratory biomarker analysis, and 1 other intervention for Adenocarcinoma of the Esophagus and 13 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This pilot clinical trial studies cyclodextrin-based nanopharmaceutical CRLX101 in treating patients with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that has progressed through at least one prior regimen of chemotherapy and cannot be removed by surgery. CRLX101 delivers the cytotoxic topoisomerase-1 inhibitor camptothecin into tumor cells and is hypothesized to interrupt the growth of tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer, Squamous Cell Carcinoma of the Esophagus, Stage IIIB Esophageal Cancer, Stage IIIB Gastric Cancer, Stage IIIC Esophageal Cancer, Stage IIIC Gastric Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2012
Enrollment StartNov 1, 2012
Primary CompletionJan 15, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.1 years ago

Interventions

cyclodextrin-based polymer-camptothecin CRLX101drug

Given IV

Laboratory biomarker analysisother

Correlative studies

Pharmacological studiesother

Correlative studies