- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138955
A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
May 5, 2022 updated by: SignPath Pharma, Inc.
: A PHASE Ib DOSE ESCALATION STUDY ON THE SAFETY, TOLERABILITY AND ACTIVITY OF LIPOSOMAL CURCUMIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Salzburg, Austria, 5020
- 3 Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
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Salzburg, Austria, 5020
- 3. Medizinische Universitatesclinik, Haematologie, Internistische Onkologie
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liposomeal curcumin ascending dose phase 1b
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicity with focus on hemolysis
Time Frame: Eight(8) weeks
|
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.
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Eight(8) weeks
|
Determine the maximum tolerated dose of lipocurc
Time Frame: in the cohort after eight ( 8) weeks of treatment
|
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.
|
in the cohort after eight ( 8) weeks of treatment
|
Maximum tolerated dose
Time Frame: eight(8) weeks
|
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.
|
eight(8) weeks
|
Maximum tolerated dose defined by < Grade 1 hematologic toxicity,
Time Frame: Outcome measured weekly x 8 weeks
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The MTD is reached when two or more patients (out of 6) at a dose level experience DLT.
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Outcome measured weekly x 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response by Recist criteria
Time Frame: Eight(8) weeks
|
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
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Eight(8) weeks
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Tumor response by resist criteria
Time Frame: 8 weeks
|
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
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8 weeks
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Tumor response
Time Frame: Eight weeks
|
The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of beneficial effect associated with the treatment.
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Eight weeks
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Benefit
Time Frame: Eight(8) weeks
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The secondary objectives are to determine the PK profiles of increasing doses, up to the MTD of liposomal curcumin, and to record any evidence of related beneficial effect associated with the treatment.
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Eight(8) weeks
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Objective change in measurable tumor size by Resist criteria
Time Frame: once after 8 weeky treatments
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once after 8 weeky treatments
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serologic changes in hepatic, renal, cardiac parameters
Time Frame: weekly x 8 weeks
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weekly x 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Greil, MD, Medicizinische Universitatsklinik Hematologie,Internistische Onkologie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
November 30, 2017
Study Completion (Actual)
February 15, 2018
Study Registration Dates
First Submitted
May 14, 2014
First Submitted That Met QC Criteria
May 14, 2014
First Posted (Estimate)
May 15, 2014
Study Record Updates
Last Update Posted (Actual)
May 11, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- Lipocurc1002/P-1-010
- 0011594-24
- SPP1002 (Other Identifier: SignPath Pharma,Inc)
- 2013-001594-24 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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