Clinical trial · Interventional
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
NCT02071537CI-TRIAL-00041918completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Chloroquine | Drug | Chloroquine | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chloroquine with Carboplatin/Gemcitabine
- description
- Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
- interventionNames
- Drug: Chloroquine
- Drug: Carboplatin
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine
- timeFrame
- Up to 12 months
Secondary outcomes (2)
- measure
- Time to Disease Progression
- timeFrame
- Up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.