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

NCT ID: NCT02138955

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-02-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomeal curcumin ascending dose phase 1b

Group Type: EXPERIMENTAL

Liposomeal curcumin

Intervention Type: DRUG

Interventions

Liposomeal curcumin

Intervention Type: DRUG

Eligibility 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%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SignPath Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Greil, MD

Role: PRINCIPAL_INVESTIGATOR

Medicizinische Universitatsklinik Hematologie,Internistische Onkologie

Locations

3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie

Salzburg, , Austria

3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie

Salzburg, , Austria

Countries

Austria

Other Identifiers

0011594-24

Identifier Type: -

Identifier Source: secondary_id

SPP1002

Identifier Type: OTHER

Identifier Source: secondary_id

2013-001594-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Lipocurc1002/P-1-010

Identifier Type: -

Identifier Source: org_study_id