Clinical trial · Interventional
A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
: A PHASE Ib DOSE ESCALATION STUDY ON THE SAFETY, TOLERABILITY AND ACTIVITY OF LIPOSOMAL CURCUMIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER
NCT02138955CI-TRIAL-00058429completedPhase 1 / Phase 2ClinicalTrials.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)
This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour infusion once weekly for 8 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients w/Advanced Cancer That Failed Std of Care Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomeal curcumin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liposomeal curcumin ascending dose phase 1b
- interventionNames
- Drug: Liposomeal curcumin
Primary outcomes (4)
- measure
- Dose limiting toxicity with focus on hemolysis
- timeFrame
- Eight(8) weeks
- description
- The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
- measure
- Determine the maximum tolerated dose of lipocurc
- timeFrame
- in the cohort after eight ( 8) weeks of treatment
- description
- The primary objectives of this study are to determine in cancer patients the safety profile of increasing doses of intravenous liposomal curcumin until the maximum tolerated dose (MTD) is determined. This will be done by assessing clinical chemistry, hematology, EKGs and urine analyses, signs and physical symptoms of adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Male and Female patients \>18 years with a histologically/cytologically confirmed diagnosis of locally advanced or metastatic cancer ,for whom no anti-tumor therapy of proven benefit is available at study enrollment. * ECOG 0-2. * Life expectancy of at least 3 months. * Measurable or non-measurable disease according to RECIST v1.1 criteria. * Patients should have at least one measurable lesion or disease which is non-measurable but can be clearly be evaluated for response. * Adequate bone marrow function as evidenced by an absolute neutrophil count :1500 cell/ul. * Hb greater than 9.5 g/dL and a platelet count greater than 100,000/ uL. * Renal function \>50ml/min with estimated creatinine clearance (eCcr) using the Cockcroft-Gault formula or serum creatinine\<1.5 mg/dL. * Adequate hepatic function as evidenced by serum total bilirubin \<3.0 mg/dL, and AST and ALT less than 5 times the upper limit of normal(ULN). * Signed informed consent. Exclusion Criteria: * Patients with lymphoma, hematological cancer or glioblastoma multiforme. * Active infection, or a fever \>38.5C within three days prior to the first day of study drug dosing. * Current or past history evidence of disease (hemolytic diathesis, hemochromatosis) that could be exacerbated by administering liposomal curcumin. * Currently on coumadin or coumadin derivatives(oral anticoagulants), or any medications classified as cytochrome p450 inhibitors or inducers. * Last systemic therapy less than three(3) weeks before (six weeks if treatment was with BCNU or CCNU). * Unresolved toxicities from prior systemic anti-cancer therapy except symptomatic motor or sensory neuro-toxicities NCI-CTC Grade \<2. * Clinically significant ECG aberrations according to the discretion of the investigator. * Left ventricular ejection fraction (LVEF) \<50%.
References
Publications (0)
Data not yet available
No reference posted for this study.