NCT02071537

Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors. Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.

Conditions

• Malignant Neoplasm
• Solid Tumors

Interventions

Type	Name	Description
DRUG	Chloroquine	Dose is 50, 100, 150, and 200 mg per day cohorts. It is given one week prior to the initiation of chemotherapy and then given for four 21 day cycles in combination with chemotherapy.
DRUG	Carboplatin	Administered day 1 of each 21 day cycle for 4-6 cycles.
DRUG	Gemcitabine	Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.

Timeline

• Start date: 2014-05-13
• Primary completion: 2018-03-03
• Completion: 2018-12-01
• First posted: 2014-02-26
• Last updated: 2019-11-25

Locations

1 site across 1 country: United States