A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer

• Status: Unknown status
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SignPath Pharma, Inc.
• Treatments: Curcumin

Criteria

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%.