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Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors

NCT02071537 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Nagla Abdel-Karim, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-13
Primary Completion
2018-03-03
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02071537 on ClinicalTrials.gov