NCT02138955

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SignPath Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with solid tumors who either failed to initially respond to approved chemotherapy or who have progressive solid tumor cancers following initial response to approved chemotherapy, are eligible for treatment in this phase 1b trial of ascending doses of intravenous liposomal curcumin following a four week period without previous chemotherapy.The escalating dose range of liposomal curcumin will be from 100mg/M2 to 300 mg/M2 in cohorts of three to 6 patients, and administered over eight hours by a syringe pump weekly for eight weeks. Safety and tolerability will be determined by drug related adverse symptoms(if any), hematologic and serologic signs at each clinic visit and by electronic communication between visits. Pharmacokinetic profiles following infusion of drug will be compared with any adverse changes, and any beneficial subjective or objective responses. When the maximum tolerated dose level is reached in any cohort , another three patients will be accrued at a preceding dose level to assure tolerability in subsequent phase 2 clinical trials.

Conditions

• Patients w/Advanced Cancer That Failed Std of Care Therapy

Interventions

Type	Name	Description
DRUG	Liposomeal curcumin

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-11-30
• Completion: 2018-02-15
• First posted: 2014-05-15
• Last updated: 2022-05-11

Locations

2 sites across 1 country: Austria