Adjuvant Effect of Chloroquine on Gemcitabine

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Chloroquine; Drug: Gemcitabine

• Registration Number: NCT01777477
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of this study is to evaluate the safety by defining the maximum tolerated dose (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will be assessed within a translational objective.

* Trial with medicinal product

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chloroquin in addition to Gemcitabine	Chloroquine	Gemcitabine 1000 mg/m2 i.v. at days 1, 8, 15 of every 28-day cycle. Chloroquine 100 mg, 200 mg or 300 mg (according to dose level) p.o. at days 2, 9, 16 of every 28-day cycle.
Chloroquin in addition to Gemcitabine	Gemcitabine	Gemcitabine 1000 mg/m2 i.v. at days 1, 8, 15 of every 28-day cycle. Chloroquine 100 mg, 200 mg or 300 mg (according to dose level) p.o. at days 2, 9, 16 of every 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.	8 weeks

Trial Locations

Locations (1)

University Hospital Zurich, Department of Oncology; 🇨🇭 Zurich, ZH, Switzerland