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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02071537

Enrollment

Registered

2014-02-26

Start date

2014-05-13

Completion date

2018-12-31

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm, Solid Tumors

Brief 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.

Interventions

DRUGChloroquine

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.

DRUGCarboplatin

Administered day 1 of each 21 day cycle for 4-6 cycles.

DRUGGemcitabine

Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed diagnosis of a malignancy that is metastatic or unresectable and for which either standard curative measures do not exist or are no longer effective and carboplatin/gemcitabine is considered a reasonable treatment option whether first line or acceptable and approved combination therapy. * Age \>18 years of age. * Performance status less than or equal 2 (Karnofsky \>60%) * Life expectancy of greater than 3 months. * Adequate labs * Measurable disease

Exclusion criteria

* Current treatment with any other investigational agents. * Patients with untreated brain metastases * History of allergic reaction attributed to compounds of similar chemical or biologic composition to chloroquine or other agents used in study.

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine	Up to 12 months

Secondary

Measure	Time frame
Time to Disease Progression	Up to 24 months
Time of Overall Survival	Up to 24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026